The following data is part of a premarket notification filed by W. L. Gore & Associates, Inc. with the FDA for Gore Seamguard Staple Line Reinforcement Material For Circular Staplers.
| Device ID | K070644 |
| 510k Number | K070644 |
| Device Name: | GORE SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL FOR CIRCULAR STAPLERS |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | W. L. GORE & ASSOCIATES, INC. 301 AIRPORT RD. P.O. BOX 1408 Elkton, MD 21922 -1408 |
| Contact | Barbara L Smith |
| Correspondent | Barbara L Smith W. L. GORE & ASSOCIATES, INC. 301 AIRPORT RD. P.O. BOX 1408 Elkton, MD 21922 -1408 |
| Product Code | FTL |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-03-08 |
| Decision Date | 2007-04-02 |
| Summary: | summary |