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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Administration, Intravascular
510(k) Number K854574
Device Name IVAC CONTROLLED RELEASE INFUSION SYSTEM
Applicant
Y
P.O. Box 85335
San Diego,  CA  92138
Applicant Contact ROBERT J BARD
Correspondent
Y
P.O. Box 85335
San Diego,  CA  92138
Correspondent Contact ROBERT J BARD
Regulation Number880.5440
Classification Product Code
FPA  
Date Received11/05/1985
Decision Date 01/23/1986
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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