The following data is part of a premarket notification filed by Swemed Lab International Ab with the FDA for Swemed Follicle Aspiration Set, Double Lumen, Single Lumen, And Luer Needle.
| Device ID | K991273 |
| 510k Number | K991273 |
| Device Name: | SWEMED FOLLICLE ASPIRATION SET, DOUBLE LUMEN, SINGLE LUMEN, AND LUER NEEDLE |
| Classification | Needle, Assisted Reproduction |
| Applicant | SWEMED LAB INTERNATIONAL AB 555 13TH ST. N.W. Washington, DC 20004 |
| Contact | Edward C Wilson Jr. |
| Correspondent | Edward C Wilson Jr. SWEMED LAB INTERNATIONAL AB 555 13TH ST. N.W. Washington, DC 20004 |
| Product Code | MQE |
| CFR Regulation Number | 884.6100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-04-13 |
| Decision Date | 1999-08-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 17350025911684 | K991273 | 000 |
| 17350025911110 | K991273 | 000 |
| 17350025911127 | K991273 | 000 |
| 17350025911134 | K991273 | 000 |
| 17350025911158 | K991273 | 000 |
| 17350025911189 | K991273 | 000 |
| 17350025911196 | K991273 | 000 |
| 17350025911226 | K991273 | 000 |
| 17350025911240 | K991273 | 000 |
| 17350025911103 | K991273 | 000 |
| 17350025911080 | K991273 | 000 |
| 17350025911073 | K991273 | 000 |
| 17350025914326 | K991273 | 000 |
| 17350025914470 | K991273 | 000 |
| 17350025911004 | K991273 | 000 |
| 07350025911014 | K991273 | 000 |
| 07350025911021 | K991273 | 000 |
| 17350025911035 | K991273 | 000 |
| 17350025911042 | K991273 | 000 |
| 17350025911066 | K991273 | 000 |
| 17350025911257 | K991273 | 000 |
| 17350025911288 | K991273 | 000 |
| 17350025911295 | K991273 | 000 |
| 17350025911509 | K991273 | 000 |
| 17350025911530 | K991273 | 000 |
| 17350025911554 | K991273 | 000 |
| 17350025911561 | K991273 | 000 |
| 17350025911578 | K991273 | 000 |
| 17350025911608 | K991273 | 000 |
| 17350025914111 | K991273 | 000 |
| 17350025914241 | K991273 | 000 |
| 17350025911493 | K991273 | 000 |
| 17350025911479 | K991273 | 000 |
| 17350025911462 | K991273 | 000 |
| 17350025911301 | K991273 | 000 |
| 17350025911318 | K991273 | 000 |
| 17350025911349 | K991273 | 000 |
| 17350025911363 | K991273 | 000 |
| 17350025911370 | K991273 | 000 |
| 17350025911387 | K991273 | 000 |
| 17350025911394 | K991273 | 000 |
| 17350025911448 | K991273 | 000 |
| 17350025914852 | K991273 | 000 |