The following data is part of a premarket notification filed by Cook, Inc. with the FDA for Gianturco-helfrich Hernis Mesh.
| Device ID | K931936 |
| 510k Number | K931936 |
| Device Name: | GIANTURCO-HELFRICH HERNIS MESH |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | COOK, INC. 925 SOUTH CURRY PIKE P.O. BOX 489 Bloomington, IN 47402 |
| Contact | April Lavender |
| Correspondent | April Lavender COOK, INC. 925 SOUTH CURRY PIKE P.O. BOX 489 Bloomington, IN 47402 |
| Product Code | FTL |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-04-19 |
| Decision Date | 1994-01-10 |