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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 K861539
Device Name NIKKISO INFUSION PUMP MODEL PFA-02
Applicant
International Medical Products, Inc.
4503 Moorland Ave.
Minneapolis,  MN  55435
Applicant Contact JEFFREY R SHIDEMAN
Correspondent
International Medical Products, Inc.
4503 Moorland Ave.
Minneapolis,  MN  55435
Correspondent Contact JEFFREY R SHIDEMAN
Regulation Number880.5725
Classification Product Code
FRN  
Date Received04/24/1986
Decision Date 07/31/1986
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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