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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 K080297
Device Name MEDRAD INTEGO PET INFUSION SYSTEM
Applicant
MEDRAD, INC.
ONE MEDRAD DR.
INDIANOLA,  PA  15051
Applicant Contact TROY A JACK
Correspondent
MEDRAD, INC.
ONE MEDRAD DR.
INDIANOLA,  PA  15051
Correspondent Contact TROY A JACK
Regulation Number880.5725
Classification Product Code
FRN  
Date Received02/04/2008
Decision Date 06/17/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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