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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 K905783
Device Name MODIFIED WALKMED 400
Applicant
MEDFUSION, INC.
3450 RIVER GREEN COURT
DULUTH,  GA  30136
Applicant Contact RUFFIN BOOTH
Correspondent
MEDFUSION, INC.
3450 RIVER GREEN COURT
DULUTH,  GA  30136
Correspondent Contact RUFFIN BOOTH
Regulation Number880.5725
Classification Product Code
FRN  
Date Received12/18/1990
Decision Date 01/11/1991
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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