Cleared Traditional

OCULAR PRESSURE REDUCER (MCCANNEL)

K852032 · Visitec Co. · Ophthalmic
Aug 1985
Decision
95d
Days
Class 2
Risk

About This 510(k) Submission

K852032 is an FDA 510(k) clearance for the OCULAR PRESSURE REDUCER (MCCANNEL), a Applicator, Ocular Pressure (Class II — Special Controls, product code LCC), submitted by Visitec Co. (Sarasota, US). The FDA issued a Cleared decision on August 12, 1985, 95 days after receiving the submission on May 9, 1985. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4610.

Submission Details

510(k) Number K852032 FDA.gov
FDA Decision Cleared SESE
Date Received May 09, 1985
Decision Date August 12, 1985
Days to Decision 95 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary —

Device Classification

Product Code LCC — Applicator, Ocular Pressure
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.4610