Cleared Traditional

STORZ D7120 PHACO HANDPIECE MAINTENANCE KIT & STORZ D7125 PHACO HANDPIECE NEEDLE WRENCH

K960024 · Storz Instrument Co. · Ophthalmic
Sep 1996
Decision
262d
Days
Class 2
Risk

About This 510(k) Submission

K960024 is an FDA 510(k) clearance for the STORZ D7120 PHACO HANDPIECE MAINTENANCE KIT & STORZ D7125 PHACO HANDPIECE NEEDLE WRENCH, 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 September 20, 1996, 262 days after receiving the submission on January 2, 1996. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4670.

Submission Details

510(k) Number K960024 FDA.gov
FDA Decision Cleared SESE
Date Received January 02, 1996
Decision Date September 20, 1996
Days to Decision 262 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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