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510(k) K905825

COLLAGEN SHIELD, VARIOUS MODELS by Chiron Ophthalmics — Product Code MOE

K905825 is an FDA 510(k) premarket notification submitted by Chiron Ophthalmics for the device "COLLAGEN SHIELD, VARIOUS MODELS". The FDA issued a decision of Substantially Equivalent on June 10, 1991. The device falls under product code MOE (Collagen Corneal Shield), a Class I device regulated under 21 CFR 886.4750. Chiron Ophthalmics has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 10, 1991
Date Received
December 31, 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

Other clearances by Chiron Ophthalmics

  • K915861 — MEDILENS-CS CORNEAL SHIELD (March 6, 1992)
  • K914311 — CHIROFLEX II LENS MICROSERT(TM) (January 27, 1992)
  • 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)
  • 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)
  • 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