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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pump, Infusion
510(k) Number K863532
Device Name MODIFIED LABELING TO MODEL 2000 AMBULATORY INFUSER
Applicant
Parker Hannifin Corp.
17352 Von Karman Ave.
Irvine,  CA  92614
Applicant Contact STEVE A WIRTZ
Correspondent
Parker Hannifin Corp.
17352 Von Karman Ave.
Irvine,  CA  92614
Correspondent Contact STEVE A WIRTZ
Regulation Number880.5725
Classification Product Code
FRN  
Date Received09/09/1986
Decision Date 01/14/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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