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510(k) K860001

BARRAQUER-KRUMEICH REFRACTIVE SET by American Medical Optics — Product Code HNO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 4, 1986
Date Received
January 2, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Keratome, Ac-Powered
Device Class
Class I
Regulation Number
886.4370
Review Panel
OP
Submission Type

Other clearances by American Medical Optics

  • K851264 — AMER. MEDICAL OPTICS MONOCULAR INDIRECT OPHTHALMAS (May 1, 1985)
  • K851263 — AMER. MEDICAL OPTIC MONOCULAR DIRECT OPHTHALMASCOP (May 1, 1985)
  • K851262 — AMER. MEDICAL OPTICAL BINOCULAR INDIRECT OPHTHALMA (April 30, 1985)
  • K844150 — MEDICAL OPTICS PHACOEMULSIFICATION KIT (December 11, 1984)
  • K843966 — ARGON/KRYPTON LASER PHOTOCOAGULATOR SYS (November 8, 1984)
  • K843965 — ARGON LASER PHOTOCOAGULATOR SYS (November 6, 1984)
  • K842504 — AMER. MEDICAL OPTICS DIGITAL KERATO- (October 1, 1984)
  • K842197 — AMERICAN MEDICAL OPTICS I/A KIT- IRRIG (October 1, 1984)
  • K842127 — AMERICAN MEDICAL OPTICS IMAGING SYS (September 7, 1984)
  • K842251 — AMERI. MEDICAL OPTICS ARGON LASER PHOTO (August 15, 1984)

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