The following data is part of a premarket notification filed by Instrumed International, Inc. with the FDA for Instrumed Vessel Dilators, Model 65-7xx,65-9xxx,66-1xxx,65-7048-65-7054.
| Device ID | K100518 |
| 510k Number | K100518 |
| Device Name: | INSTRUMED VESSEL DILATORS, MODEL 65-7XX,65-9XXX,66-1XXX,65-7048-65-7054 |
| Classification | Dilator, Vessel, Surgical |
| Applicant | INSTRUMED INTERNATIONAL, INC. 626 COOPER COURT Schaumburg, IL 60173 |
| Contact | Michael Massong |
| Correspondent | Michael Massong INSTRUMED INTERNATIONAL, INC. 626 COOPER COURT Schaumburg, IL 60173 |
| Product Code | DWP |
| CFR Regulation Number | 870.4475 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-02-23 |
| Decision Date | 2010-08-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00190660029920 | K100518 | 000 |
| 00190660029678 | K100518 | 000 |
| 00190660029661 | K100518 | 000 |
| 00190660029654 | K100518 | 000 |
| 00190660029647 | K100518 | 000 |
| 00190660029630 | K100518 | 000 |
| 00190660029623 | K100518 | 000 |
| 00190660029616 | K100518 | 000 |
| 00190660029609 | K100518 | 000 |
| 00190660029593 | K100518 | 000 |
| 00190660029586 | K100518 | 000 |
| 00190660029579 | K100518 | 000 |
| 00190660029562 | K100518 | 000 |
| 00887482085585 | K100518 | 000 |
| 00887482085578 | K100518 | 000 |
| B09927002520 | K100518 | 000 |
| B09927002300 | K100518 | 000 |
| 00190660029685 | K100518 | 000 |
| 00190660029692 | K100518 | 000 |
| 00190660029913 | K100518 | 000 |
| 00190660029906 | K100518 | 000 |
| 00190660029890 | K100518 | 000 |
| 00190660029883 | K100518 | 000 |
| 00190660029876 | K100518 | 000 |
| 00190660029869 | K100518 | 000 |
| 00190660029852 | K100518 | 000 |
| 00190660029845 | K100518 | 000 |
| 00190660029838 | K100518 | 000 |
| 00190660029821 | K100518 | 000 |
| 00190660029814 | K100518 | 000 |
| 00190660029807 | K100518 | 000 |
| 00190660029791 | K100518 | 000 |
| 00190660029784 | K100518 | 000 |
| 00190660029777 | K100518 | 000 |
| 00190660029708 | K100518 | 000 |
| B09927002250 | K100518 | 000 |
| B09927002240 | K100518 | 000 |
| B09927002230 | K100518 | 000 |
| B09927002040 | K100518 | 000 |
| B09927002030 | K100518 | 000 |
| B09927002020 | K100518 | 000 |
| 00192896104785 | K100518 | 000 |
| 00192896104778 | K100518 | 000 |
| 00192896104761 | K100518 | 000 |
| 00192896104754 | K100518 | 000 |
| 00192896104747 | K100518 | 000 |
| 00192896105072 | K100518 | 000 |
| 00192896105065 | K100518 | 000 |
| 00192896105089 | K100518 | 000 |
| 00190660211950 | K100518 | 000 |
| 00190660211943 | K100518 | 000 |
| 00190660211936 | K100518 | 000 |
| 00190660211929 | K100518 | 000 |
| 00192896112087 | K100518 | 000 |
| B09927002050 | K100518 | 000 |
| B09927002060 | K100518 | 000 |
| B09927002220 | K100518 | 000 |
| B09927002210 | K100518 | 000 |
| B09927002200 | K100518 | 000 |
| B09927002190 | K100518 | 000 |
| B09927002180 | K100518 | 000 |
| B09927002170 | K100518 | 000 |
| B09927002160 | K100518 | 000 |
| B09927002150 | K100518 | 000 |
| B09927002140 | K100518 | 000 |
| B09927002130 | K100518 | 000 |
| B09927002120 | K100518 | 000 |
| B09927002110 | K100518 | 000 |
| B09927002100 | K100518 | 000 |
| B09927002090 | K100518 | 000 |
| B09927002080 | K100518 | 000 |
| B09927002070 | K100518 | 000 |
| 00810123206582 | K100518 | 000 |
| B09927001200 | K100518 | 000 |
| B09927000330 | K100518 | 000 |
| B09927000320 | K100518 | 000 |
| B09927000310 | K100518 | 000 |
| B09927000300 | K100518 | 000 |
| B09927000220 | K100518 | 000 |
| B09927000210 | K100518 | 000 |
| B0992700010P0 | K100518 | 000 |
| B09927000100 | K100518 | 000 |
| B0992700009P0 | K100518 | 000 |
| B09927000090 | K100518 | 000 |
| B0992700008P0 | K100518 | 000 |
| B09927000080 | K100518 | 000 |
| B0992700007P0 | K100518 | 000 |
| B09927000070 | K100518 | 000 |
| B0992700006P0 | K100518 | 000 |
| B09927000060 | K100518 | 000 |
| B09927000340 | K100518 | 000 |
| B09927000350 | K100518 | 000 |
| B09927001000 | K100518 | 000 |
| B09927000500 | K100518 | 000 |
| B09927000230 | K100518 | 000 |
| B09927000200 | K100518 | 000 |
| B09927002660 | K100518 | 000 |
| B09927002640 | K100518 | 000 |
| B09927002620 | K100518 | 000 |
| B09927002600 | K100518 | 000 |
| B09927002500 | K100518 | 000 |
| B09927000530 | K100518 | 000 |
| B09927000520 | K100518 | 000 |
| B09927000510 | K100518 | 000 |
| B09927000390 | K100518 | 000 |
| B09927000380 | K100518 | 000 |
| B09927000370 | K100518 | 000 |
| B09927000360 | K100518 | 000 |
| B0992700005P0 | K100518 | 000 |
| B09927000050 | K100518 | 000 |
| B0992700004P0 | K100518 | 000 |
| 00190660030100 | K100518 | 000 |
| 00190660030094 | K100518 | 000 |
| 00190660030087 | K100518 | 000 |
| 00190660030070 | K100518 | 000 |
| 00190660030063 | K100518 | 000 |
| 00190660030056 | K100518 | 000 |
| 00190660030049 | K100518 | 000 |
| 00190660030032 | K100518 | 000 |
| 00190660030025 | K100518 | 000 |
| 00190660030018 | K100518 | 000 |
| 00190660030001 | K100518 | 000 |
| 00190660029999 | K100518 | 000 |
| 00190660029982 | K100518 | 000 |
| 00190660029975 | K100518 | 000 |
| 00190660029968 | K100518 | 000 |
| 00190660029951 | K100518 | 000 |
| 00190660030117 | K100518 | 000 |
| 00190660030124 | K100518 | 000 |
| B09927000040 | K100518 | 000 |
| B0992700003P0 | K100518 | 000 |
| B09927000030 | K100518 | 000 |
| B0992700002P0 | K100518 | 000 |
| B09927000020 | K100518 | 000 |
| B09927000010 | K100518 | 000 |
| 00190660031343 | K100518 | 000 |
| 00190660031282 | K100518 | 000 |
| 00190660031275 | K100518 | 000 |
| 00190660031268 | K100518 | 000 |
| 00190660031251 | K100518 | 000 |
| 00190660031244 | K100518 | 000 |
| 00190660030162 | K100518 | 000 |
| 00190660030155 | K100518 | 000 |
| 00190660030148 | K100518 | 000 |
| 00190660030131 | K100518 | 000 |
| 00190660029944 | K100518 | 000 |