Cleared Traditional

STORZ D4600 AIR EXCHANGE LINE PACK

K962131 · Storz Instrument Co. · Ophthalmic
Aug 1996
Decision
81d
Days
Class 2
Risk

About This 510(k) Submission

K962131 is an FDA 510(k) clearance for the STORZ D4600 AIR EXCHANGE LINE 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 23, 1996, 81 days after receiving the submission on June 3, 1996. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4670.

Submission Details

510(k) Number K962131 FDA.gov
FDA Decision Cleared SESE
Date Received June 03, 1996
Decision Date August 23, 1996
Days to Decision 81 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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