The following data is part of a premarket notification filed by Synergetics, Inc with the FDA for Versavit.
| Device ID | K121675 |
| 510k Number | K121675 |
| Device Name: | VERSAVIT |
| Classification | Instrument, Vitreous Aspiration And Cutting, Ac-powered |
| Applicant | SYNERGETICS, INC 3845 CORPORATE CENTRE DRIVE O'fallon, MO 63368 |
| Contact | Dan Regan |
| Correspondent | Ned Devine UNDERWRITERS LABORATORIES, INC. 333 PFINGSTEN RD. Northbrook, IL 60062 |
| Product Code | HQE |
| CFR Regulation Number | 886.4150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2012-06-06 |
| Decision Date | 2012-06-21 |
| Summary: | summary |