The following data is part of a premarket notification filed by Aspide Medical with the FDA for Surgimesh Xd.
| Device ID | K092233 |
| 510k Number | K092233 |
| Device Name: | SURGIMESH XD |
| 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 | 2009-07-23 |
| Decision Date | 2010-06-25 |
| Summary: | summary |