ULTRASONIC TIPS

Unit, Phacofragmentation

COOPERVISION, INC.

The following data is part of a premarket notification filed by Coopervision, Inc. with the FDA for Ultrasonic Tips.

Pre-market Notification Details

Device IDK812126
510k NumberK812126
Device Name:ULTRASONIC TIPS
ClassificationUnit, Phacofragmentation
Applicant COOPERVISION, INC. PERMALENS HOUSE 1 BOTLEY ROAD, HEDGE END Southampton,  GB S033hb
Product CodeHQC  
CFR Regulation Number886.4670 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1981-07-27
Decision Date1981-09-18

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