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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, Elastomeric
510(k) Number K011117
Device Name MPS ACACIA MEDFLO INFUSION (LI) AND MPS ACACIA MEDFLO INFUSION (LI) KEEP VEIN OPEN (KVO) ELASTOMERIC PUMPS
Applicant
Mps Acacia
499 Nibus St., Suite E
Brea,  CA  92821
Applicant Contact FERGIE F FERGUSON
Correspondent
Mps Acacia
499 Nibus St., Suite E
Brea,  CA  92821
Correspondent Contact FERGIE F FERGUSON
Regulation Number880.5725
Classification Product Code
MEB  
Subsequent Product Code
FRN  
Date Received04/12/2001
Decision Date 07/09/2001
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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