BIO-COR EXT COLLAGEN CORNEAL SHIELD

Collagen Corneal Shield

BAUSCH & LOMB, INC.

The following data is part of a premarket notification filed by Bausch & Lomb, Inc. with the FDA for Bio-cor Ext Collagen Corneal Shield.

Pre-market Notification Details

Device IDK874225
510k NumberK874225
Device Name:BIO-COR EXT COLLAGEN CORNEAL SHIELD
ClassificationCollagen Corneal Shield
Applicant BAUSCH & LOMB, INC. 11300 49TH STREET, NORTH Clearwater,  FL  34622
ContactMichael Stevens
CorrespondentMichael Stevens
BAUSCH & LOMB, INC. 11300 49TH STREET, NORTH Clearwater,  FL  34622
Product CodeMOE  
CFR Regulation Number886.4750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-10-16
Decision Date1988-01-22

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