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510(k) K884363

LABELING CHANGES TO BIO-COR II COLLANGEN CORNEAL by Bausch & Lomb Pharmaceutical, Inc. — Product Code MOE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 29, 1988
Date Received
October 20, 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

Other clearances by Bausch & Lomb Pharmaceutical, Inc.

  • K884962 — ADDIT. INDICATIONS FOR BIO-COR EXT COLLAGEN CORNEA (February 9, 1990)
  • K884960 — ADDIT. INDICATION FOR FYODOROV COLLAGEN CORNEAL (February 13, 1989)
  • K884961 — ADDIT. INDICATIONS FOR BIO-COR II COLLAGEN CORNEAL (February 13, 1989)
  • K884362 — LABELING CHANGES TO FYODOROV COLLAGEN CORNEAL SHLD (November 29, 1988)
  • K884364 — LABELING CHANGES TO BIO-COR EXT COLLANGEN CORNEAL (November 29, 1988)

Other clearances for product code MOE

  • K944872 — BIO-COR COLLAGEN CORNEAL SHIELD (July 26, 1995)
  • K915861 — MEDILENS-CS CORNEAL SHIELD (March 6, 1992)
  • K914529 — SOFTSHIELD(TM) 12, 24, 72 COLLAGEN CORNEAL SHIELDS (November 13, 1991)
  • K913148 — COLLAGEN SHIELD FOR ACUTE CARE (October 15, 1991)
  • K905825 — COLLAGEN SHIELD, VARIOUS MODELS (June 10, 1991)
  • 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)