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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 K082182
Device Name AP 34 MULTI-THERAPY INFUSION PUMP
Applicant
Q-Core, Ltd.
P.O. Box 3341
14 Hamefalsim St. Kiryat Aryeh
Petach Tikva,  IL 49130
Applicant Contact ASHER KASSEL
Correspondent
Kema Quality B.V.
4377 County Line Rd.
Chalfont,  PA  18914
Correspondent Contact J. A. VAN VUGT
Regulation Number880.5725
Classification Product Code
FRN  
Subsequent Product Codes
FPA   MRZ  
Date Received08/01/2008
Decision Date 08/15/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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