Cleared Traditional

STORZ PREMIERE II MICROSURGICAL SYSTEM (CX SERIES)

K961310 · Storz Instrument Co. · Ophthalmic
Jun 1996
Decision
84d
Days
Class 2
Risk

About This 510(k) Submission

K961310 is an FDA 510(k) clearance for the STORZ PREMIERE II MICROSURGICAL SYSTEM (CX SERIES), 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 27, 1996, 84 days after receiving the submission on April 4, 1996. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4670.

Submission Details

510(k) Number K961310 FDA.gov
FDA Decision Cleared SESE
Date Received April 04, 1996
Decision Date June 27, 1996
Days to Decision 84 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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