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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, Pca
510(k) Number K915063
Device Name IVAC PC ANIFUSER
Applicant
Y
P.O. Box 85335
San Diego,  CA  92138
Applicant Contact JUDITH A.FAIRCHILD
Correspondent
Y
P.O. Box 85335
San Diego,  CA  92138
Correspondent Contact JUDITH A.FAIRCHILD
Regulation Number880.5725
Classification Product Code
MEA  
Date Received11/08/1991
Decision Date 06/03/1992
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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