The following data is part of a premarket notification filed by W.l. Gore & Associates,inc with the FDA for Gore Smoother Ii And Gore Bptb.
| Device ID | K941269 |
| 510k Number | K941269 |
| Device Name: | GORE SMOOTHER II AND GORE BPTB |
| Classification | Arthroscope |
| Applicant | W.L. GORE & ASSOCIATES,INC 1500 N. FOURTH ST. P.O. BOX 3000 Flagstaff, AZ 86003 |
| Contact | Larry J Kovach |
| Correspondent | Larry J Kovach W.L. GORE & ASSOCIATES,INC 1500 N. FOURTH ST. P.O. BOX 3000 Flagstaff, AZ 86003 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-03-16 |
| Decision Date | 1994-05-19 |