Cleared Traditional

STORZ D7116 MICROVIT VITRECTOMY CUTTER EXTENSION

K960003 · Storz Instrument Co. · Ophthalmic
Aug 1996
Decision
240d
Days
Class 2
Risk

About This 510(k) Submission

K960003 is an FDA 510(k) clearance for the STORZ D7116 MICROVIT VITRECTOMY CUTTER EXTENSION, 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 August 29, 1996, 240 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 K960003 FDA.gov
FDA Decision Cleared SESE
Date Received January 02, 1996
Decision Date August 29, 1996
Days to Decision 240 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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