KRATZ NOVA-SERT

Lens, Guide, Intraocular

COOPERVISION, INC.

The following data is part of a premarket notification filed by Coopervision, Inc. with the FDA for Kratz Nova-sert.

Pre-market Notification Details

Device IDK871440
510k NumberK871440
Device Name:KRATZ NOVA-SERT
ClassificationLens, Guide, Intraocular
Applicant COOPERVISION, INC. COOPERVISION CILCO 3190 160TH AVENUE S.E. Bellevue,  WA  98008
ContactTom Trotter
CorrespondentTom Trotter
COOPERVISION, INC. COOPERVISION CILCO 3190 160TH AVENUE S.E. Bellevue,  WA  98008
Product CodeKYB  
CFR Regulation Number886.4300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-04-13
Decision Date1987-05-07

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