The following data is part of a premarket notification filed by Visitec Co. with the FDA for Visitec Vitrectomy Unit.
| Device ID | K896622 |
| 510k Number | K896622 |
| Device Name: | VISITEC VITRECTOMY UNIT |
| Classification | Instrument, Vitreous Aspiration And Cutting, Battery-powered |
| Applicant | VISITEC CO. 7575 COMMERCE COURT Sarasota, FL 34243 -3218 |
| Contact | Liaquat Allarakhia |
| Correspondent | Liaquat Allarakhia VISITEC CO. 7575 COMMERCE COURT Sarasota, FL 34243 -3218 |
| Product Code | HKP |
| CFR Regulation Number | 886.4150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-11-21 |
| Decision Date | 1990-04-04 |