The following data is part of a premarket notification filed by W.l. Gore & Associates with the FDA for Gore Seamguard Bioabsorbable Staple Line Reinforcement Material.
| Device ID | K053202 |
| 510k Number | K053202 |
| Device Name: | GORE SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | W.L. GORE & ASSOCIATES 3450 W. KILTIE LANE Flagstaff, AZ 86001 |
| Contact | Michael Ivey |
| Correspondent | Michael Ivey W.L. GORE & ASSOCIATES 3450 W. KILTIE LANE Flagstaff, AZ 86001 |
| Product Code | FTL |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-11-16 |
| Decision Date | 2005-12-07 |
| Summary: | summary |