The following data is part of a premarket notification filed by Visitec Co. with the FDA for Visitec Ophthalmic Aspiration Unit Model 100.
| Device ID | K853961 |
| 510k Number | K853961 |
| Device Name: | VISITEC OPHTHALMIC ASPIRATION UNIT MODEL 100 |
| Classification | Instrument, Vitreous Aspiration And Cutting, Ac-powered |
| Applicant | VISITEC CO. 2043 WHITFIELD PARK DR. Sarasota, FL 33580 |
| Contact | Thomas B Givens |
| Correspondent | Thomas B Givens VISITEC CO. 2043 WHITFIELD PARK DR. Sarasota, FL 33580 |
| Product Code | HQE |
| CFR Regulation Number | 886.4150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-09-25 |
| Decision Date | 1985-12-13 |