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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 K851447
Device Name IVAC MODEL 580 GENER. USE VOLUMETRIC INFUSION PUMP
Applicant
Y
10300 CAMPUS POINT DR.
SAN DIEGO,  CA  92121 -1579
Applicant Contact ALBERT P PEDO
Correspondent
Y
10300 CAMPUS POINT DR.
SAN DIEGO,  CA  92121 -1579
Correspondent Contact ALBERT P PEDO
Regulation Number880.5725
Classification Product Code
FRN  
Date Received03/25/1985
Decision Date 05/08/1985
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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