Cleared Traditional

STORZ DP4505 VITREOUS MEMBRANE DISSECTOR

K953576 · Storz Instrument Co. · Ophthalmic
Sep 1995
Decision
45d
Days
Class 2
Risk

About This 510(k) Submission

K953576 is an FDA 510(k) clearance for the STORZ DP4505 VITREOUS MEMBRANE DISSECTOR, a Instrument, Vitreous Aspiration And Cutting, Ac-powered (Class II — Special Controls, product code HQE), submitted by Storz Instrument Co. (St. Louis, US). The FDA issued a Cleared decision on September 14, 1995, 45 days after receiving the submission on July 31, 1995. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4150.

Submission Details

510(k) Number K953576 FDA.gov
FDA Decision Cleared SESE
Date Received July 31, 1995
Decision Date September 14, 1995
Days to Decision 45 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code HQE — Instrument, Vitreous Aspiration And Cutting, Ac-powered
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.4150

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