COOPER VISION SYSTEM VI U/S MODULE

Unit, Phacofragmentation

COOPERVISION, INC.

The following data is part of a premarket notification filed by Coopervision, Inc. with the FDA for Cooper Vision System Vi U/s Module.

Pre-market Notification Details

Device IDK853070
510k NumberK853070
Device Name:COOPER VISION SYSTEM VI U/S MODULE
ClassificationUnit, Phacofragmentation
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 CodeHQC  
CFR Regulation Number886.4670 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-07-22
Decision Date1985-08-20

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