The following data is part of a premarket notification filed by Omega Surgical Instruments, Inc. with the FDA for K-wires And Steinmann Pins.
| Device ID | K941434 |
| 510k Number | K941434 |
| Device Name: | K-WIRES AND STEINMANN PINS |
| Classification | Pin, Fixation, Smooth |
| Applicant | OMEGA SURGICAL INSTRUMENTS, INC. G-8305 S. SAGINAW ST. Grand Blanc, MI 48439 |
| Contact | Gary L Adam |
| Correspondent | Gary L Adam OMEGA SURGICAL INSTRUMENTS, INC. G-8305 S. SAGINAW ST. Grand Blanc, MI 48439 |
| Product Code | HTY |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-03-24 |
| Decision Date | 1994-10-03 |