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510(k) K842197

AMERICAN MEDICAL OPTICS I/A KIT- IRRIG by American Medical Optics — Product Code HQE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 1, 1984
Date Received
June 4, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Vitreous Aspiration And Cutting, Ac-Powered
Device Class
Class II
Regulation Number
886.4150
Review Panel
OP
Submission Type

Other clearances by American Medical Optics

  • K860001 — BARRAQUER-KRUMEICH REFRACTIVE SET (February 4, 1986)
  • K851263 — AMER. MEDICAL OPTIC MONOCULAR DIRECT OPHTHALMASCOP (May 1, 1985)
  • K851264 — AMER. MEDICAL OPTICS MONOCULAR INDIRECT OPHTHALMAS (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)
  • K842127 — AMERICAN MEDICAL OPTICS IMAGING SYS (September 7, 1984)
  • K842250 — AMER. MEDICAL OPTICS ARGON/KRYPTON LASE (August 15, 1984)

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