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.
| Device ID | K053200 |
| 510k Number | K053200 |
| Device Name: | GORE SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | W.L. GORE & ASSOCIATES,INC 3750 W. KILTIE LN. Flagstaff, AZ 86001 -0900 |
| Contact | Michael Ivey |
| Correspondent | Michael Ivey W.L. GORE & ASSOCIATES,INC 3750 W. KILTIE LN. Flagstaff, AZ 86001 -0900 |
| 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 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00733132600786 | K053200 | 000 |
| 00733132600779 | K053200 | 000 |
| 00733132600762 | K053200 | 000 |
| 00733132600755 | K053200 | 000 |
| 00733132655526 | K053200 | 000 |
| 00733132655519 | K053200 | 000 |
| 00733132655502 | K053200 | 000 |
| 00733132655496 | K053200 | 000 |