The following data is part of a premarket notification filed by Visitec Co. with the FDA for Visitec Ophthalmic Fluid Distrib- Set.
| Device ID | K843487 |
| 510k Number | K843487 |
| Device Name: | VISITEC OPHTHALMIC FLUID DISTRIB- SET |
| Classification | Unit, Phacofragmentation |
| Applicant | VISITEC CO. 2043 WHITFIELD PARK DR. Sarasota, FL 33580 |
| Contact | Eugene H Beckstein |
| Correspondent | Eugene H Beckstein VISITEC CO. 2043 WHITFIELD PARK DR. Sarasota, FL 33580 |
| Product Code | HQC |
| CFR Regulation Number | 886.4670 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-09-06 |
| Decision Date | 1985-03-13 |