SERIES TEN THOUSAND OCUTOME

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 Series Ten Thousand Ocutome.

Pre-market Notification Details

Device IDK871871
510k NumberK871871
Device Name:SERIES TEN THOUSAND OCUTOME
ClassificationInstrument, Vitreous Aspiration And Cutting, Ac-powered
Applicant COOPERVISION, INC. 17701 COWAN AVE.P. O. BOX 19587 Irvine,  CA  92713
ContactDavid W Krapf
CorrespondentDavid W 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 Received1987-05-13
Decision Date1987-06-11

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