Cleared Traditional

PHACO HANDPIECE FOR PHACO FRAGMENTATION MACHINES, PHACO SLEEVE FOR ATTACHMENT TO PHACO HANDPIECES

K953959 · Microsurgical Technology, Inc. · Ophthalmic
Nov 1995
Decision
87d
Days
Class 2
Risk

About This 510(k) Submission

K953959 is an FDA 510(k) clearance for the PHACO HANDPIECE FOR PHACO FRAGMENTATION MACHINES, PHACO SLEEVE FOR ATTACHMENT TO PHACO HANDPIECES, a Unit, Phacofragmentation (Class II — Special Controls, product code HQC), submitted by Microsurgical Technology, Inc. (Redmond, US). The FDA issued a Cleared decision on November 17, 1995, 87 days after receiving the submission on August 22, 1995. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4670.

Submission Details

510(k) Number K953959 FDA.gov
FDA Decision Cleared SESE
Date Received August 22, 1995
Decision Date November 17, 1995
Days to Decision 87 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement

Device Classification

Product Code HQC — Unit, Phacofragmentation
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.4670

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