The following data is part of a premarket notification filed by Synergetics, Inc. with the FDA for Ophthalmic Surgical Pneumatic Scissors Driver.
| Device ID | K932668 |
| 510k Number | K932668 |
| Device Name: | OPHTHALMIC SURGICAL PNEUMATIC SCISSORS DRIVER |
| Classification | Instrument, Vitreous Aspiration And Cutting, Ac-powered |
| Applicant | SYNERGETICS, INC. 17466 CHESTERFIELD AIRPORT RD. Chesterfield, MI |
| Contact | Gregg D Scheller |
| Correspondent | Gregg D Scheller SYNERGETICS, INC. 17466 CHESTERFIELD AIRPORT RD. Chesterfield, MI |
| Product Code | HQE |
| CFR Regulation Number | 886.4150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-06-02 |
| Decision Date | 1994-02-23 |