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510(k) K883393

CAPD DISPOSABLE Y SYSTEM - DY SET by Medionics International , Ltd. — Product Code KDJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 3, 1988
Date Received
August 9, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, Administration, For Peritoneal Dialysis, Disposable
Device Class
Class II
Regulation Number
876.5630
Review Panel
GU
Submission Type

Other clearances by Medionics International , Ltd.

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  • K994218 — EASY CARE AND TUBING SETS (February 10, 2000)
  • K945567 — QC CAP (February 7, 1995)
  • K910173 — SELECTRA AND TUBING SETS (January 13, 1992)
  • 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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