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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 K894037
Device Name IVAC(R) SPACE.SAVER(TM) VOLUMETRIC PUMP MODEL 599
Applicant
Y
P.O. BOX 85335
SAN DIEGO,  CA  92138 -5335
Applicant Contact G CHRISTIAN
Correspondent
Y
P.O. BOX 85335
SAN DIEGO,  CA  92138 -5335
Correspondent Contact G CHRISTIAN
Regulation Number880.5725
Classification Product Code
FRN  
Date Received06/06/1989
Decision Date 08/28/1989
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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