Cleared Traditional

PHACO TIP

K950881 · American Optical Corp. · Ophthalmic
Sep 1995
Decision
191d
Days
Class 2
Risk

About This 510(k) Submission

K950881 is an FDA 510(k) clearance for the PHACO TIP, a Unit, Phacofragmentation (Class II — Special Controls, product code HQC), submitted by American Optical Corp. (Irvine, US). The FDA issued a Cleared decision on September 6, 1995, 191 days after receiving the submission on February 27, 1995. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4670.

Submission Details

510(k) Number K950881 FDA.gov
FDA Decision Cleared SESE
Date Received February 27, 1995
Decision Date September 06, 1995
Days to Decision 191 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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