The following data is part of a premarket notification filed by W.l. Gore & Associates,inc with the FDA for Modification To Seamguard Staple Line Reinforcement Material.
| Device ID | K010936 |
| 510k Number | K010936 |
| Device Name: | MODIFICATION TO SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL |
| Classification | Mesh, Surgical, Non-absorbable, Staple Line Reinforcement |
| Applicant | W.L. GORE & ASSOCIATES,INC 3450 WEST KILTIE LN. Flagstaff,, AZ 86002 |
| Contact | R. Larry Pratt |
| Correspondent | R. Larry Pratt W.L. GORE & ASSOCIATES,INC 3450 WEST KILTIE LN. Flagstaff,, AZ 86002 |
| Product Code | OXD |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-03-28 |
| Decision Date | 2001-05-21 |