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510(k) K994218

EASY CARE AND TUBING SETS by Medionics International, Inc. — Product Code FKX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 10, 2000
Date Received
December 15, 1999
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Peritoneal, Automatic Delivery
Device Class
Class II
Regulation Number
876.5630
Review Panel
GU
Submission Type

Other clearances by Medionics International, Inc.

  • K130441 — FALLER STYLET (April 19, 2013)
  • K993149 — PERITONEAL DIALYSIS CATHETERS AND ADAPTERS (April 28, 2000)
  • K945567 — QC CAP (February 7, 1995)
  • K910173 — SELECTRA AND TUBING SETS (January 13, 1992)
  • K883393 — CAPD DISPOSABLE Y SYSTEM - DY SET (November 3, 1988)
  • K842305 — C.A.P.D. AUTOMATIC HEATER PDH 200 (June 25, 1984)
  • K832141 — MICROSTAR VC1 VOLUMETRIC CYCLER (October 14, 1983)
  • K831766 — MICROSTAR VCI (October 14, 1983)
  • K821328 — C.A.P.D. AUTOMATIC HEATER #PDC 2000 HCP (July 28, 1982)

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