SERIES TEN THOUSAND COMPACT

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 Compact.

Pre-market Notification Details

Device IDK861565
510k NumberK861565
Device Name:SERIES TEN THOUSAND COMPACT
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 Received1986-04-25
Decision Date1986-07-11

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.