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510(k) K915861

MEDILENS-CS CORNEAL SHIELD by Chiron Ophthalmics — Product Code MOE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 6, 1992
Date Received
December 31, 1991
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 Chiron Ophthalmics

  • K914311 — CHIROFLEX II LENS MICROSERT(TM) (January 27, 1992)
  • K905825 — COLLAGEN SHIELD, VARIOUS MODELS (June 10, 1991)
  • K903575 — CHIROFLEX FORCEPS (December 21, 1990)
  • K903574 — CHIROFLEX LENS MICROSERT (September 17, 1990)
  • K901880 — MEDILENS(TM) CORNEAL SHIELD (July 2, 1990)
  • K894162 — OPTISOL (January 12, 1990)
  • K885015 — COI 72 HR COLLAGEN SHIELD (June 23, 1989)
  • K885016 — COI 24 HR COLLAGEN SHIELD (February 1, 1989)
  • K882762 — COLLAGEN SHIELD (September 12, 1988)

Other clearances for product code MOE

  • K944872 — BIO-COR COLLAGEN CORNEAL SHIELD (July 26, 1995)
  • 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)
  • K884960 — ADDIT. INDICATION FOR FYODOROV COLLAGEN CORNEAL (February 13, 1989)