DISPOSABLE CYSTOTOME

Cystotome

COOPERVISION, INC.

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

Pre-market Notification Details

Device IDK831916
510k NumberK831916
Device Name:DISPOSABLE CYSTOTOME
ClassificationCystotome
Applicant COOPERVISION, INC. PERMALENS HOUSE 1 BOTLEY ROAD, HEDGE END Southampton,  GB S033hb
Product CodeHNY  
CFR Regulation Number886.4350 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-06-14
Decision Date1983-07-12

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