Cleared Traditional

STORZ I/A HANDPIECES

K951463 · Storz Instrument Co. · Ophthalmic
Oct 1995
Decision
211d
Days
Class 2
Risk

About This 510(k) Submission

K951463 is an FDA 510(k) clearance for the STORZ I/A HANDPIECES, 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 October 27, 1995, 211 days after receiving the submission on March 30, 1995. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4670.

Submission Details

510(k) Number K951463 FDA.gov
FDA Decision Cleared SESE
Date Received March 30, 1995
Decision Date October 27, 1995
Days to Decision 211 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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