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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 K844718
Device Name MODEL 1001
Applicant
A0KFUSION SYSTEMS, INC.
1250 POWERS FERRY RD.
SUITE 200
MARIETA,  GA  30067
Applicant Contact WILLIAM D ARTHUR
Correspondent
A0KFUSION SYSTEMS, INC.
1250 POWERS FERRY RD.
SUITE 200
MARIETA,  GA  30067
Correspondent Contact WILLIAM D ARTHUR
Regulation Number880.5725
Classification Product Code
FRN  
Date Received12/04/1984
Decision Date 01/28/1985
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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