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 | K150551 |
| 510k Number | K150551 |
| Device Name: | GORE SEAMGUARD Reinforcement |
| Classification | Mesh, Surgical, Absorbable, Staple Line Reinforcement |
| Applicant | W. L. GORE & ASSOCIATES, INC. 1505 N. FOURTH STREET Flagstaff, AZ 86004 |
| Contact | Barbara L. Smith |
| Correspondent | Barbara L. Smith W. L. GORE & ASSOCIATES, INC. 1505 N. FOURTH STREET Flagstaff, AZ 86004 |
| Product Code | OXC |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-03-04 |
| Decision Date | 2015-03-30 |
| Summary: | summary |