Cleared Traditional

RELIEF VALVE-HONAN INTRAOC. PRESSURE

K820526 · The Lebanon Corp. · Ophthalmic
Mar 1982
Decision
27d
Days
Class 2
Risk

About This 510(k) Submission

K820526 is an FDA 510(k) clearance for the RELIEF VALVE-HONAN INTRAOC. PRESSURE, a Applicator, Ocular Pressure (Class II — Special Controls, product code LCC), submitted by The Lebanon Corp. (Mchenry, US). The FDA issued a Cleared decision on March 25, 1982, 27 days after receiving the submission on February 26, 1982. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4610.

Submission Details

510(k) Number K820526 FDA.gov
FDA Decision Cleared SESE
Date Received February 26, 1982
Decision Date March 25, 1982
Days to Decision 27 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