Cleared Traditional

STORZ MICROFLOW AND STORZ STANDARD PHACOEMULSIFICATION NEEDLES

K971439 · Storz Instrument Co. · Ophthalmic
Jun 1997
Decision
60d
Days
Class 2
Risk

About This 510(k) Submission

K971439 is an FDA 510(k) clearance for the STORZ MICROFLOW AND STORZ STANDARD PHACOEMULSIFICATION NEEDLES, 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 June 17, 1997, 60 days after receiving the submission on April 18, 1997. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4670.

Submission Details

510(k) Number K971439 FDA.gov
FDA Decision Cleared SESE
Date Received April 18, 1997
Decision Date June 17, 1997
Days to Decision 60 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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