Cleared Traditional

STORZ E8010 ERGOTEC/PREMIERE ADAPTOR

K964743 · Storz Instrument Co. · Ophthalmic
Feb 1997
Decision
69d
Days
Class 2
Risk

About This 510(k) Submission

K964743 is an FDA 510(k) clearance for the STORZ E8010 ERGOTEC/PREMIERE ADAPTOR, 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 February 3, 1997, 69 days after receiving the submission on November 26, 1996. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4150.

Submission Details

510(k) Number K964743 FDA.gov
FDA Decision Cleared SESE
Date Received November 26, 1996
Decision Date February 03, 1997
Days to Decision 69 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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