The following data is part of a premarket notification filed by W. L. Gore & Associates, Inc. with the FDA for Gore Seamguard Reinforcement.
| Device ID | K131658 |
| 510k Number | K131658 |
| Device Name: | GORE SEAMGUARD REINFORCEMENT |
| Classification | Mesh, Surgical, Absorbable, Staple Line Reinforcement |
| Applicant | W. L. GORE & ASSOCIATES, INC. 301 AIRPORT RD. Elkton, MD 21921 |
| Contact | Barbara L Smith |
| Correspondent | Barbara L Smith W. L. GORE & ASSOCIATES, INC. 301 AIRPORT RD. Elkton, MD 21921 |
| Product Code | OXC |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-06-06 |
| Decision Date | 2013-09-06 |
| Summary: | summary |