The following data is part of a premarket notification filed by W.l. Gore & Associates,inc with the FDA for Gore Laparoscopic Suture Passer.
| Device ID | K935986 |
| 510k Number | K935986 |
| Device Name: | GORE LAPAROSCOPIC SUTURE PASSER |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | W.L. GORE & ASSOCIATES,INC 301 AIRPORT RD Elkton, MD 21922 -1408 |
| Contact | R. Larry Pratt |
| Correspondent | R. Larry Pratt W.L. GORE & ASSOCIATES,INC 301 AIRPORT RD Elkton, MD 21922 -1408 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-12-14 |
| Decision Date | 1994-05-12 |