Cleared Traditional

STORZ DP4600 ANTERIOR INTRAOCULAR PRESSURE CONTROL PACK

K961820 · Storz Instrument Co. · Ophthalmic
Jul 1996
Decision
76d
Days
Class 2
Risk

About This 510(k) Submission

K961820 is an FDA 510(k) clearance for the STORZ DP4600 ANTERIOR INTRAOCULAR PRESSURE CONTROL PACK, 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 July 25, 1996, 76 days after receiving the submission on May 10, 1996. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4670.

Submission Details

510(k) Number K961820 FDA.gov
FDA Decision Cleared SESE
Date Received May 10, 1996
Decision Date July 25, 1996
Days to Decision 76 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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