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510(k) K874224

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

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

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Other clearances for product code MOE

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  • K902558 — COLLAGEN SHIELD FOR ACUTE CARE (August 17, 1990)
  • K901880 — MEDILENS(TM) CORNEAL SHIELD (July 2, 1990)
  • K896449 — IM COLLAGEN SHIELD (May 24, 1990)
  • K884962 — ADDIT. INDICATIONS FOR BIO-COR EXT COLLAGEN CORNEA (February 9, 1990)
  • K885015 — COI 72 HR COLLAGEN SHIELD (June 23, 1989)