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510(k) K874020

ULTRACARE(TM) AUTOMATED PATIENT ASSIST DEVICE by Abbott Laboratories — Product Code KPF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 29, 1988
Date Received
October 2, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

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Other clearances for product code KPF

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  • K821328 — C.A.P.D. AUTOMATIC HEATER #PDC 2000 HCP (July 28, 1982)
  • K802831 — GAMBRO PERITONEAL DIALYSIS MONITOR (December 18, 1980)
  • K800496 — CYCLER W/5 OR 10 HR. FILL/DWELL TIMER (July 21, 1980)
  • K791676 — PERITONEAL DIALYSIS CYCLER MODEL PDC1000 (December 6, 1979)