The following data is part of a premarket notification filed by Omega Surgical Instruments, Inc. with the FDA for Bur, Surgical, General & Plastic Surgery.
| Device ID | K933595 |
| 510k Number | K933595 |
| Device Name: | BUR, SURGICAL, GENERAL & PLASTIC SURGERY |
| Classification | Blade, Saw, General & Plastic Surgery, Surgical |
| Applicant | OMEGA SURGICAL INSTRUMENTS, INC. 11415 ORCHARDVIEW DR. Fenton, MI 48430 |
| Contact | Gary L Adam |
| Correspondent | Gary L Adam OMEGA SURGICAL INSTRUMENTS, INC. 11415 ORCHARDVIEW DR. Fenton, MI 48430 |
| Product Code | GFA |
| CFR Regulation Number | 878.4820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-07-26 |
| Decision Date | 1994-03-16 |