510(k) K874225

BIO-COR EXT COLLAGEN CORNEAL SHIELD by Bausch & Lomb, Inc. — Product Code MOE

K874225 is an FDA 510(k) premarket notification submitted by Bausch & Lomb, Inc. for the device "BIO-COR EXT COLLAGEN CORNEAL SHIELD". The FDA issued a decision of Substantially Equivalent on January 22, 1988. The device falls under product code MOE (Collagen Corneal Shield), a Class I device regulated under 21 CFR 886.4750. Bausch & Lomb, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 22, 1988
Date Received
October 16, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Collagen Corneal Shield
Device Class
Class I
Regulation Number
886.4750
Review Panel
OP
Submission Type