510(k) K885016

COI 24 HR COLLAGEN SHIELD by Chiron Ophthalmics — Product Code MOE

K885016 is an FDA 510(k) premarket notification submitted by Chiron Ophthalmics for the device "COI 24 HR COLLAGEN SHIELD". The FDA issued a decision of Substantially Equivalent on February 1, 1989. The device falls under product code MOE (Collagen Corneal Shield), a Class I device regulated under 21 CFR 886.4750. Chiron Ophthalmics has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 1, 1989
Date Received
December 5, 1988
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