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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 K872764
Device Name IVAC NITROGLYCERIN & LIPID ADMIN. SET MODEL S75053
Applicant
Y
P.O. BOX 85335
SAN DIEGO,  CA  92138 -5335
Applicant Contact ROBERT J BARD
Correspondent
Y
P.O. BOX 85335
SAN DIEGO,  CA  92138 -5335
Correspondent Contact ROBERT J BARD
Regulation Number880.5725
Classification Product Code
FRN  
Date Received07/13/1987
Decision Date 11/03/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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