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510(k) K863532

MODIFIED LABELING TO MODEL 2000 AMBULATORY INFUSER by Parker Hannifin Corp. — Product Code FRN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 14, 1987
Date Received
September 9, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Infusion
Device Class
Class II
Regulation Number
880.5725
Review Panel
HO
Submission Type

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  • K831747 — PLASMA THERAPY TUBESET-E100 SERIES (June 30, 1983)
  • K830818 — ASAHI BLOOD/PLASMA PUMP #ABP-01A & (April 12, 1983)

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