Cleared Traditional

DPS 100 MULTIPORT ILLUMINATION SYSTEM (MIS)

K933445 · Storz Instrument Co. · Ophthalmic
Sep 1994
Decision
437d
Days
Class 2
Risk

About This 510(k) Submission

K933445 is an FDA 510(k) clearance for the DPS 100 MULTIPORT ILLUMINATION SYSTEM (MIS), a Transilluminator, Ac-powered (Class II — Special Controls, product code HJM), submitted by Storz Instrument Co. (St. Louis, US). The FDA issued a Cleared decision on September 23, 1994, 437 days after receiving the submission on July 13, 1993. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1945.

Submission Details

510(k) Number K933445 FDA.gov
FDA Decision Cleared SESE
Date Received July 13, 1993
Decision Date September 23, 1994
Days to Decision 437 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code HJM — Transilluminator, Ac-powered
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.1945

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