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510(k) K914311

CHIROFLEX II LENS MICROSERT(TM) by Chiron Ophthalmics — Product Code HQL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 27, 1992
Date Received
September 26, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Intraocular Lens
Device Class
Class III
Regulation Number
886.3600
Review Panel
OP
Submission Type

Other clearances by Chiron Ophthalmics

  • K915861 — MEDILENS-CS CORNEAL SHIELD (March 6, 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 HQL

  • K913626 — SOFTRANS INJECTOR (December 18, 1991)
  • K842892 — NIDEK DIGITAL KERATOMETER (October 5, 1984)
  • K842504 — AMER. MEDICAL OPTICS DIGITAL KERATO- (October 1, 1984)
  • K771933 — CILCO ANTERIOR CHAMBER LENS (January 26, 1978)