Cleared Traditional

WOLDOFF PRISMATIC BICONCAVE LENS

K894421 · Ocular Instruments, Inc. · Ophthalmic
Oct 1989
Decision
79d
Days
Class 2
Risk

About This 510(k) Submission

K894421 is an FDA 510(k) clearance for the WOLDOFF PRISMATIC BICONCAVE 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 October 4, 1989, 79 days after receiving the submission on July 17, 1989. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1385.

Submission Details

510(k) Number K894421 FDA.gov
FDA Decision Cleared SESE
Date Received July 17, 1989
Decision Date October 04, 1989
Days to Decision 79 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary —

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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