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510(k) K944872

BIO-COR COLLAGEN CORNEAL SHIELD by Bausch & Lomb Healthcare and Optics Worldwide — Product Code MOE

K944872 is an FDA 510(k) premarket notification submitted by Bausch & Lomb Healthcare and Optics Worldwide for the device "BIO-COR COLLAGEN CORNEAL SHIELD". The FDA issued a decision of Substantially Equivalent on July 26, 1995. The device falls under product code MOE (Collagen Corneal Shield), a Class I device regulated under 21 CFR 886.4750.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 26, 1995
Date Received
October 3, 1994
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 for product code MOE

  • 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)
  • K884961 — ADDIT. INDICATIONS FOR BIO-COR II COLLAGEN CORNEAL (February 13, 1989)

FDA data resources