The following data is part of a premarket notification filed by Aspide Medical with the FDA for Surgimesh Xb - Skirted.
| Device ID | K120025 |
| 510k Number | K120025 |
| Device Name: | SURGIMESH XB - SKIRTED |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | ASPIDE MEDICAL 555 THIRTEENTH ST. NW COLUMBIA SQUARE Washington, DC 20004 -1109 |
| Contact | John J Smith |
| Correspondent | John J Smith 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-01-03 |
| Decision Date | 2012-06-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850011929124 | K120025 | 000 |
| 00850011929117 | K120025 | 000 |
| 00850011929100 | K120025 | 000 |
| 00850011929094 | K120025 | 000 |