The following data is part of a premarket notification filed by Davis & Geck, Inc. with the FDA for Polypropylene Mesh (various Sizes).
| Device ID | K962971 |
| 510k Number | K962971 |
| Device Name: | POLYPROPYLENE MESH (VARIOUS SIZES) |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | DAVIS & GECK, INC. 1915 OLIVE ST. St. Louis, MO 63103 |
| Contact | Stephen J Tamsett |
| Correspondent | Stephen J Tamsett DAVIS & GECK, INC. 1915 OLIVE ST. St. Louis, MO 63103 |
| Product Code | FTL |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-07-31 |
| Decision Date | 1996-09-16 |