The following data is part of a premarket notification filed by Aspide Medical with the FDA for Surgimesh Wn.
| Device ID | K061445 |
| 510k Number | K061445 |
| Device Name: | SURGIMESH WN |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | ASPIDE MEDICAL 555 THIRTEENTH ST. NW COLUMBIA SQUARE Washington, DC 20004 -1109 |
| Contact | Howard M Holstein |
| Correspondent | Howard M Holstein ASPIDE MEDICAL 555 THIRTEENTH ST. NW COLUMBIA SQUARE Washington, DC 20004 -1109 |
| Product Code | FTL |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-05-24 |
| Decision Date | 2007-02-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850011929247 | K061445 | 000 |
| 00850011929292 | K061445 | 000 |
| 00850011929131 | K061445 | 000 |
| 00850011929148 | K061445 | 000 |
| 00850011929155 | K061445 | 000 |
| 00850011929179 | K061445 | 000 |
| 00850011929186 | K061445 | 000 |
| 00850011929193 | K061445 | 000 |
| 00850011929209 | K061445 | 000 |
| 00850011929216 | K061445 | 000 |
| 00850011929223 | K061445 | 000 |
| 00850011929230 | K061445 | 000 |
| 00850011929278 | K061445 | 000 |