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510(k) K833405

IRRIGATION ASPIRATION KIT by American Medical Optics — Product Code HQC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 6, 1984
Date Received
September 30, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Phacofragmentation
Device Class
Class II
Regulation Number
886.4670
Review Panel
OP
Submission Type

Other clearances by American Medical Optics

  • K860001 — BARRAQUER-KRUMEICH REFRACTIVE SET (February 4, 1986)
  • 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)
  • K842197 — AMERICAN MEDICAL OPTICS I/A KIT- IRRIG (October 1, 1984)
  • K842504 — AMER. MEDICAL OPTICS DIGITAL KERATO- (October 1, 1984)
  • K842127 — AMERICAN MEDICAL OPTICS IMAGING SYS (September 7, 1984)

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