COI 72 HR COLLAGEN SHIELD

Collagen Corneal Shield

CHIRON OPHTHALMICS

The following data is part of a premarket notification filed by Chiron Ophthalmics with the FDA for Coi 72 Hr Collagen Shield.

Pre-market Notification Details

Device IDK885015
510k NumberK885015
Device Name:COI 72 HR COLLAGEN SHIELD
ClassificationCollagen Corneal Shield
Applicant CHIRON OPHTHALMICS 9342 JERONIMO RD. Irvine,  CA  92718
ContactMcgarvey
CorrespondentMcgarvey
CHIRON OPHTHALMICS 9342 JERONIMO RD. Irvine,  CA  92718
Product CodeMOE  
CFR Regulation Number886.4750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-12-05
Decision Date1989-06-23

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