Cleared Traditional

STORZ DP5200 IRRIGATION ADDMINISTRATION SET PACK

K961831 · Storz Instrument Co. · Ophthalmic
Aug 1996
Decision
85d
Days
Class 2
Risk

About This 510(k) Submission

K961831 is an FDA 510(k) clearance for the STORZ DP5200 IRRIGATION ADDMINISTRATION SET 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 August 6, 1996, 85 days after receiving the submission on May 13, 1996. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4670.

Submission Details

510(k) Number K961831 FDA.gov
FDA Decision Cleared SESE
Date Received May 13, 1996
Decision Date August 06, 1996
Days to Decision 85 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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