The following data is part of a premarket notification filed by Aspide Medical with the FDA for Surgimesh Xb.
| Device ID | K072974 |
| 510k Number | K072974 |
| Device Name: | SURGIMESH XB |
| 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 | 2007-10-22 |
| Decision Date | 2008-08-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850011929070 | K072974 | 000 |
| 00850011929063 | K072974 | 000 |
| 00850011929056 | K072974 | 000 |
| 00850011929049 | K072974 | 000 |
| 00850011929032 | K072974 | 000 |
| 00850011929025 | K072974 | 000 |
| 00850011929018 | K072974 | 000 |
| 00850011929001 | K072974 | 000 |