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510(k) K974561

MOISTAIR FLUID AIR TUBING SET by American Medical Devices, Inc. — Product Code KYG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 19, 1998
Date Received
December 5, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Irrigation, Ocular Surgery
Device Class
Class I
Regulation Number
886.4360
Review Panel
OP
Submission Type

Other clearances by American Medical Devices, Inc.

  • K971853 — ENDOVIEW SPPHIRE LENS SET (August 6, 1997)
  • K970882 — ENDOLIGHT END IRRIGATING ENDO-ILLUMINATOR (20 GA. AND 19 GA.) (June 24, 1997)
  • K970873 — ENDOSOFT SOFT TIP NEEDLE (20 GA. AND 19 GA.) (May 20, 1997)
  • K970875 — ENDOLIGHT FIBEROPTIC ENDO-ILLUMINATOR (20 GA. & 19 GA.) (May 20, 1997)
  • K970878 — ENDOLIGHT FIBEROPTIC REGULAR MONOFILAMENT AND FINE MONOFILAMENT (May 6, 1997)

Other clearances for product code KYG

  • K010353 — MED-LOGICS DISPOSABLE ALK TUBING (April 27, 2001)
  • K003036 — TURBO-FLOW INFUSION CANNULA 19 GAGE,20 GAGE,23 GAGE, 25 GAGE, MODEL 101019,10102 (December 22, 2000)
  • K993591 — BLADEWORKS DISPOSABLE ALK TUBING (December 28, 1999)
  • K981116 — SOVEREIGN CATARACT EXTRACTION SYSTEM (May 19, 1998)
  • K980647 — EYE IRRIGATOR MODEL #2020 (May 15, 1998)
  • K971173 — ML DISPOSABLE ALK TUBING (May 22, 1997)
  • K970161 — HEDGES CORNEAL WETTING PAK (March 25, 1997)
  • K954842 — D.O.R.C. VFI/VFE SYSTEM (April 15, 1996)
  • K945171 — DISPOSABLE & RESUABLE IRRIGATION/ASPIRATION HANDPIECE (February 8, 1995)
  • K940392 — PEREGRINE PIC MINIPULATOR (August 23, 1994)