Cleared Traditional

50 DEGREE HRI PRISM LENS

K941420 · Ocular Instruments, Inc. · Ophthalmic
Aug 1994
Decision
159d
Days
Class 2
Risk

About This 510(k) Submission

K941420 is an FDA 510(k) clearance for the 50 DEGREE HRI PRISM LENS, a Lens, Contact, Polymethylmethacrylate, Diagnostic (Class II — Special Controls, product code HJK), submitted by Ocular Instruments, Inc. (Bellevue, US). The FDA issued a Cleared decision on August 29, 1994, 159 days after receiving the submission on March 23, 1994. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1385.

Submission Details

510(k) Number K941420 FDA.gov
FDA Decision Cleared SESE
Date Received March 23, 1994
Decision Date August 29, 1994
Days to Decision 159 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement

Device Classification

Product Code HJK — Lens, Contact, Polymethylmethacrylate, Diagnostic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.1385

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