Cleared Traditional

STORZ DP4310DELUXE PHACO PACK WITHOUT REFLUX

K955901 · Storz Instrument Co. · Ophthalmic
Mar 1996
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K955901 is an FDA 510(k) clearance for the STORZ DP4310DELUXE PHACO PACK WITHOUT REFLUX, 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 28, 1996, 90 days after receiving the submission on December 29, 1995. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4670.

Submission Details

510(k) Number K955901 FDA.gov
FDA Decision Cleared SESE
Date Received December 29, 1995
Decision Date March 28, 1996
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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