The following data is part of a premarket notification filed by Resorba Medical Gmbh with the FDA for Pga Resorba, Pga Resoquick, Glycolon.
| Device ID | K143584 |
| 510k Number | K143584 |
| Device Name: | PGA RESORBA, PGA RESOQUICK, GLYCOLON |
| Classification | Suture, Absorbable, Synthetic, Polyglycolic Acid |
| Applicant | RESORBA MEDICAL GMBH AM FLACHMOOOR 16 Nuremberg, DE 90475 |
| Contact | Karl Josef Beck |
| Correspondent | Karl Josef Beck RESORBA MEDICAL GMBH AM FLACHMOOOR 16 Nuremberg, DE 90475 |
| Product Code | GAM |
| CFR Regulation Number | 878.4493 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-12-18 |
| Decision Date | 2015-11-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| E203OD012039 | K143584 | 000 |
| E203OD03202 | K143584 | 000 |
| E203OD032029 | K143584 | 000 |
| E203OD03203 | K143584 | 000 |
| E203OD03204 | K143584 | 000 |
| E203OD03205 | K143584 | 000 |
| E203OD03206 | K143584 | 000 |
| E203OD03400 | K143584 | 000 |
| E203OD034009 | K143584 | 000 |
| E203OD03500 | K143584 | 000 |
| E203OD035009 | K143584 | 000 |
| E203OD03600 | K143584 | 000 |
| E203OD036009 | K143584 | 000 |
| E203OD032019 | K143584 | 000 |
| E203OD03201 | K143584 | 000 |
| E203OD012109 | K143584 | 000 |
| E203OD012119 | K143584 | 000 |
| E203OD012129 | K143584 | 000 |
| E203OD01214 | K143584 | 000 |
| E203OD013009 | K143584 | 000 |
| E203OD03100 | K143584 | 000 |
| E203OD031009 | K143584 | 000 |
| E203OD03101 | K143584 | 000 |
| E203OD03102 | K143584 | 000 |
| E203OD03103 | K143584 | 000 |
| E203OD03200 | K143584 | 000 |
| E203OD032009 | K143584 | 000 |
| E203OD03700 | K143584 | 000 |
| E203OD03701 | K143584 | 000 |
| E203USPA1013 | K143584 | 000 |
| E203USPA10244 | K143584 | 000 |
| E203USPA10248 | K143584 | 000 |
| E203USPA1025 | K143584 | 000 |
| E203USPA10250 | K143584 | 000 |
| E203USPA102509 | K143584 | 000 |
| E203USPA10251 | K143584 | 000 |
| E203USPA10253 | K143584 | 000 |
| E203USPA10254 | K143584 | 000 |
| E203USPA10265 | K143584 | 000 |
| E203USPA10266 | K143584 | 000 |
| E203USPA1028 | K143584 | 000 |
| E203USPA102919 | K143584 | 000 |
| E203USPA10243 | K143584 | 000 |
| E203USPA10232 | K143584 | 000 |
| E203USPA1015 | K143584 | 000 |
| E203USPA10159 | K143584 | 000 |
| E203USPA1019 | K143584 | 000 |
| E203USPA1021 | K143584 | 000 |
| E203USPA10210 | K143584 | 000 |
| E203USPA10211 | K143584 | 000 |
| E203USPA10216 | K143584 | 000 |
| E203USPA10217 | K143584 | 000 |
| E203USPA10218 | K143584 | 000 |
| E203USPA10224 | K143584 | 000 |
| E203USPA10225 | K143584 | 000 |
| E203USPA10226 | K143584 | 000 |
| E203USPA10293 | K143584 | 000 |
| E203OD012029 | K143584 | 000 |
| E203OD01204 | K143584 | 000 |
| E203JCG60231 | K143584 | 000 |
| E203JCG60232 | K143584 | 000 |
| E203JCG60602 | K143584 | 000 |
| E203JCG60605 | K143584 | 000 |
| E203JCG60606 | K143584 | 000 |
| E203JCG60613 | K143584 | 000 |
| E203JCG60620 | K143584 | 000 |
| E203JCG61101 | K143584 | 000 |
| E203JCG61410 | K143584 | 000 |
| E203JCG61411 | K143584 | 000 |
| E203JCG61412 | K143584 | 000 |
| E203JCG61413 | K143584 | 000 |
| E203JCG60230 | K143584 | 000 |
| E203JCG60216 | K143584 | 000 |
| E203OD01205 | K143584 | 000 |
| E203JCG41416 | K143584 | 000 |
| E203JCG41420 | K143584 | 000 |
| E203JCG41421 | K143584 | 000 |
| E203JCG41422 | K143584 | 000 |
| E203JCG41509 | K143584 | 000 |
| E203JCG41527 | K143584 | 000 |
| E203JCG60201 | K143584 | 000 |
| E203JCG60202 | K143584 | 000 |
| E203JCG60203 | K143584 | 000 |
| E203JCG60204 | K143584 | 000 |
| E203JCG60215 | K143584 | 000 |
| E203JCG61414 | K143584 | 000 |
| E203JCG61415 | K143584 | 000 |
| E203JCG61417 | K143584 | 000 |
| E203JCG61524 | K143584 | 000 |
| E203JCG61528 | K143584 | 000 |
| E203JCG61529 | K143584 | 000 |
| E203JCG65109 | K143584 | 000 |
| E203JCG65116 | K143584 | 000 |
| E203JCG65120 | K143584 | 000 |
| E203JCG65121 | K143584 | 000 |
| E203JCG65122 | K143584 | 000 |
| E203JCG65127 | K143584 | 000 |
| E203OD011009 | K143584 | 000 |
| E203OD011019 | K143584 | 000 |
| E203OD012009 | K143584 | 000 |
| E203JCG61515 | K143584 | 000 |
| E203JCG61514 | K143584 | 000 |
| E203JCG61501 | K143584 | 000 |
| E203JCG61502 | K143584 | 000 |
| E203JCG61503 | K143584 | 000 |
| E203JCG61504 | K143584 | 000 |
| E203JCG61505 | K143584 | 000 |
| E203JCG61506 | K143584 | 000 |
| E203JCG61507 | K143584 | 000 |
| E203JCG61508 | K143584 | 000 |
| E203JCG61510 | K143584 | 000 |
| E203JCG61511 | K143584 | 000 |
| E203JCG61512 | K143584 | 000 |
| E203JCG61513 | K143584 | 000 |
| E203OD012019 | K143584 | 000 |
| E203USPA1210 | K143584 | 000 |
| E203USPB41501 | K143584 | 000 |
| E203USPB41502 | K143584 | 000 |
| E203USPB41503 | K143584 | 000 |
| E203USPB41504 | K143584 | 000 |
| E203USPB41505 | K143584 | 000 |
| E203USPB41506 | K143584 | 000 |
| E203USPB41507 | K143584 | 000 |
| E203USPB41508 | K143584 | 000 |
| E203USPB41509 | K143584 | 000 |
| E203USPB41510 | K143584 | 000 |
| E203USPB41511 | K143584 | 000 |
| E203USPB41512 | K143584 | 000 |
| E203USPB41421 | K143584 | 000 |
| E203USPB41420 | K143584 | 000 |
| E203USPB40201 | K143584 | 000 |
| E203USPB40202 | K143584 | 000 |
| E203USPB40203 | K143584 | 000 |
| E203USPB40204 | K143584 | 000 |
| E203USPB40231 | K143584 | 000 |
| E203USPB40232 | K143584 | 000 |
| E203USPB40241 | K143584 | 000 |
| E203USPB40243 | K143584 | 000 |
| E203USPB40244 | K143584 | 000 |
| E203USPB40324 | K143584 | 000 |
| E203USPB40334 | K143584 | 000 |
| E203USPB414149 | K143584 | 000 |
| E203USPB41513 | K143584 | 000 |
| E203USPB41514 | K143584 | 000 |
| E203USPB41515 | K143584 | 000 |
| E203USPR30204 | K143584 | 000 |
| E203USPR30214 | K143584 | 000 |
| E203USPR31104 | K143584 | 000 |
| E203USPR31505 | K143584 | 000 |
| E203USPS5125 | K143584 | 000 |
| E203USPS515 | K143584 | 000 |
| E203USPS6125 | K143584 | 000 |
| E203USPS615 | K143584 | 000 |
| E203USPS715 | K143584 | 000 |
| E203USPU4125 | K143584 | 000 |
| E203USPU5125 | K143584 | 000 |
| E203USPU6125 | K143584 | 000 |
| E203USPL102 | K143584 | 000 |
| E203USPL101 | K143584 | 000 |
| E203USPB41516 | K143584 | 000 |
| E203USPB41520 | K143584 | 000 |
| E203USPB41521 | K143584 | 000 |
| E203USPB41522 | K143584 | 000 |
| E203USPB41523 | K143584 | 000 |
| E203USPB41524 | K143584 | 000 |
| E203USPB41526 | K143584 | 000 |
| E203USPB41527 | K143584 | 000 |
| E203USPB41528 | K143584 | 000 |
| E203USPB41529 | K143584 | 000 |
| E203USPB41530 | K143584 | 000 |
| E203USPB4172 | K143584 | 000 |
| E203USPU665 | K143584 | 000 |
| E203USPA1174 | K143584 | 000 |
| E203USPA1030 | K143584 | 000 |
| E203USPA10353 | K143584 | 000 |
| E203USPA10356 | K143584 | 000 |
| E203USPA10362 | K143584 | 000 |
| E203USPA10363 | K143584 | 000 |
| E203USPA10368 | K143584 | 000 |
| E203USPA1037 | K143584 | 000 |
| E203USPA10370 | K143584 | 000 |
| E203USPA10371 | K143584 | 000 |
| E203USPA103819 | K143584 | 000 |
| E203USPA103829 | K143584 | 000 |
| E203USPA10383 | K143584 | 000 |
| E203USPA10384 | K143584 | 000 |
| E203USPA10349 | K143584 | 000 |
| E203USPA10348 | K143584 | 000 |
| E203USPA1031 | K143584 | 000 |
| E203USPA10311 | K143584 | 000 |
| E203USPA10312 | K143584 | 000 |
| E203USPA1032 | K143584 | 000 |
| E203USPA10324 | K143584 | 000 |
| E203USPA10325 | K143584 | 000 |
| E203USPA10326 | K143584 | 000 |
| E203USPA10328 | K143584 | 000 |
| E203USPA10336 | K143584 | 000 |
| E203USPA10342 | K143584 | 000 |
| E203USPA10343 | K143584 | 000 |
| E203USPA10346 | K143584 | 000 |
| E203USPA10385 | K143584 | 000 |
| E203USPA10386 | K143584 | 000 |
| E203USPA1048 | K143584 | 000 |
| E203USPA1146 | K143584 | 000 |
| E203USPA1150 | K143584 | 000 |
| E203USPA1151 | K143584 | 000 |
| E203USPA11510 | K143584 | 000 |
| E203USPA11517 | K143584 | 000 |
| E203USPA11519 | K143584 | 000 |
| E203USPA1152 | K143584 | 000 |
| E203USPA11520 | K143584 | 000 |
| E203USPA11522 | K143584 | 000 |
| E203USPA11523 | K143584 | 000 |
| E203USPA1154 | K143584 | 000 |
| E203USPA1155 | K143584 | 000 |
| E203USPA1145 | K143584 | 000 |
| E203USPA1143 | K143584 | 000 |
| E203USPA1056 | K143584 | 000 |
| E203USPA1065 | K143584 | 000 |
| E203USPA1110 | K143584 | 000 |
| E203USPA1111 | K143584 | 000 |
| E203USPA1116 | K143584 | 000 |
| E203USPA1119 | K143584 | 000 |
| E203USPA1140 | K143584 | 000 |
| E203USPA1141 | K143584 | 000 |
| E203USPA11413 | K143584 | 000 |
| E203USPA11416 | K143584 | 000 |
| E203USPA11424 | K143584 | 000 |
| E203USPA11425 | K143584 | 000 |
| E203USPA1158 | K143584 | 000 |