The following data is part of a premarket notification filed by Gerard Medical, Inc. with the FDA for Hernia Mesh Introduction System.
| Device ID | K945060 |
| 510k Number | K945060 |
| Device Name: | HERNIA MESH INTRODUCTION SYSTEM |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | GERARD MEDICAL, INC. 90 WORCESTER RD. Charlton, MA 01507 |
| Contact | Richard Cayer |
| Correspondent | Richard Cayer GERARD MEDICAL, INC. 90 WORCESTER RD. Charlton, MA 01507 |
| Product Code | FTL |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-10-14 |
| Decision Date | 1995-03-02 |