The following data is part of a premarket notification filed by Visitec Co. with the FDA for Ocular Pressure Reducer (mccannel).
| Device ID | K852032 |
| 510k Number | K852032 |
| Device Name: | OCULAR PRESSURE REDUCER (MCCANNEL) |
| Classification | Applicator, Ocular Pressure |
| 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 | LCC |
| CFR Regulation Number | 886.4610 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-05-09 |
| Decision Date | 1985-08-12 |