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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 K843274
Device Name MODULAR VOLUMETRIC INFUSION PUMP SYS
Applicant
AMERICAN EDWARDS LABORATORIES
p.o. box 11150
17221 red hill ave.(irvine)
santa ana,  CA  92711 -1150
Applicant Contact daina graham
Correspondent
AMERICAN EDWARDS LABORATORIES
p.o. box 11150
17221 red hill ave.(irvine)
santa ana,  CA  92711 -1150
Correspondent Contact daina graham
Regulation Number880.5725
Classification Product Code
FRN  
Date Received08/20/1984
Decision Date 10/19/1984
Decision substantially equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
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