The following data is part of a premarket notification filed by W.l. Gore & Associates,inc with the FDA for Gore Laparoscopic Suture Passer (non-sterile).
| Device ID | K945953 |
| 510k Number | K945953 |
| Device Name: | GORE LAPAROSCOPIC SUTURE PASSER (NON-STERILE) |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | W.L. GORE & ASSOCIATES,INC 301 AIRPORT RD Elkton, MD 21922 -1408 |
| Contact | R L Pratt |
| Correspondent | R L 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 | 1994-12-06 |
| Decision Date | 1995-03-03 |