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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Electric For Gravity Flow Infusion Systems
510(k) Number K910323
Device Name BEDSIDE FLUID MANAGEMENT SYSTEM 1000 (FMS-1000)
Applicant
UAB RESEARCH FOUNDATION
P.O. BOX 1000
UAB STATION
BIRMINGHAM,  AL  35294
Applicant Contact KENNETH J ROOZEN
Correspondent
UAB RESEARCH FOUNDATION
P.O. BOX 1000
UAB STATION
BIRMINGHAM,  AL  35294
Correspondent Contact KENNETH J ROOZEN
Regulation Number880.2420
Classification Product Code
FLN  
Date Received01/24/1991
Decision Date 10/03/1991
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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