LABELING CHANGES TO BIO-COR II COLLANGEN CORNEAL

Collagen Corneal Shield

BAUSCH & LOMB PHARMACEUTICAL, INC.

The following data is part of a premarket notification filed by Bausch & Lomb Pharmaceutical, Inc. with the FDA for Labeling Changes To Bio-cor Ii Collangen Corneal.

Pre-market Notification Details

Device IDK884363
510k NumberK884363
Device Name:LABELING CHANGES TO BIO-COR II COLLANGEN CORNEAL
ClassificationCollagen Corneal Shield
Applicant BAUSCH & LOMB PHARMACEUTICAL, INC. 11300 49TH.STREET NORTH Clearwater,  FL  34622
ContactH Duffell
CorrespondentH Duffell
BAUSCH & LOMB PHARMACEUTICAL, INC. 11300 49TH.STREET NORTH Clearwater,  FL  34622
Product CodeMOE  
CFR Regulation Number886.4750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-10-20
Decision Date1988-11-29

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