INTERCASSETTE, INTERKIT, UNIVERSAL PAK & CASSETTE

Instrument, Vitreous Aspiration And Cutting, Ac-powered

COOPERVISION, INC.

The following data is part of a premarket notification filed by Coopervision, Inc. with the FDA for Intercassette, Interkit, Universal Pak & Cassette.

Pre-market Notification Details

Device IDK890300
510k NumberK890300
Device Name:INTERCASSETTE, INTERKIT, UNIVERSAL PAK & CASSETTE
ClassificationInstrument, Vitreous Aspiration And Cutting, Ac-powered
Applicant COOPERVISION, INC. 17701 COWAN AVE.P. O. BOX 19587 Irvine,  CA  92713
ContactDave Krapf
CorrespondentDave Krapf
COOPERVISION, INC. 17701 COWAN AVE.P. O. BOX 19587 Irvine,  CA  92713
Product CodeHQE  
CFR Regulation Number886.4150 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-01-19
Decision Date1989-04-17

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