510(k) K902558

COLLAGEN SHIELD FOR ACUTE CARE by Vitaphore Corp. — Product Code MOE

K902558 is an FDA 510(k) premarket notification submitted by Vitaphore Corp. for the device "COLLAGEN SHIELD FOR ACUTE CARE". The FDA issued a decision of Substantially Equivalent on August 17, 1990. The device falls under product code MOE (Collagen Corneal Shield), a Class I device regulated under 21 CFR 886.4750. Vitaphore Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 17, 1990
Date Received
June 11, 1990
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