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510(k) K831766

MICROSTAR VCI by Medionics International , Ltd. — Product Code FKX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 14, 1983
Date Received
June 1, 1983
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)
  • 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)
  • K821328 — C.A.P.D. AUTOMATIC HEATER #PDC 2000 HCP (July 28, 1982)

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