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510(k) K910173

SELECTRA AND TUBING SETS by Medionics International , Ltd. — Product Code FKX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 13, 1992
Date Received
January 15, 1991
Clearance Type
Traditional
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

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  • K945567 — QC CAP (February 7, 1995)
  • 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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