Cleared Traditional

STORZ DP4101 BASIC I/A PACK

K953078 · Storz Instrument Co. · Ophthalmic
Aug 1995
Decision
35d
Days
Class 2
Risk

About This 510(k) Submission

K953078 is an FDA 510(k) clearance for the STORZ DP4101 BASIC I/A 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 7, 1995, 35 days after receiving the submission on July 3, 1995. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4670.

Submission Details

510(k) Number K953078 FDA.gov
FDA Decision Cleared SESE
Date Received July 03, 1995
Decision Date August 07, 1995
Days to Decision 35 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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