The following data is part of a premarket notification filed by W. L. Gore & Associates, Inc. with the FDA for Seamguard Bioabsorbable Staple Line Reinforcement Material.
| Device ID | K030782 |
| 510k Number | K030782 |
| Device Name: | SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL |
| Classification | Mesh, Surgical |
| Applicant | W. L. GORE & ASSOCIATES, INC. 3450 WEST KILTIE LN. Flagstaff, AZ 86001 |
| Contact | Mike Johnson |
| Correspondent | Mike Johnson W. L. GORE & ASSOCIATES, INC. 3450 WEST KILTIE LN. Flagstaff, AZ 86001 |
| Product Code | FTM |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-03-11 |
| Decision Date | 2003-04-21 |
| Summary: | summary |