Cleared Traditional

STORZ PREMIERE(R) MICROSURGICAL SYSTEM

K946227 · Storz Instrument Co. · Ophthalmic
Mar 1995
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K946227 is an FDA 510(k) clearance for the STORZ PREMIERE(R) MICROSURGICAL SYSTEM, a Unit, Phacofragmentation (Class II — Special Controls, product code HQC), submitted by Storz Instrument Co. (St. Louis, US). The FDA issued a Cleared decision on March 22, 1995, 90 days after receiving the submission on December 22, 1994. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4670.

Submission Details

510(k) Number K946227 FDA.gov
FDA Decision Cleared SESE
Date Received December 22, 1994
Decision Date March 22, 1995
Days to Decision 90 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code HQC — Unit, Phacofragmentation
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.4670

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