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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 K073051
Device Name MEDRAD CONTINUUM MR INFUSION SYSTEM WITH WIRELESS REMOTE ACCESSORY
Applicant
MEDRAD, INC.
ONE MEDRAD DR.
INDIANOLA,  PA  15051
Applicant Contact LESLIE S O'NAN
Correspondent
MEDRAD, INC.
ONE MEDRAD DR.
INDIANOLA,  PA  15051
Correspondent Contact LESLIE S O'NAN
Regulation Number880.5725
Classification Product Code
FRN  
Date Received10/29/2007
Decision Date 05/30/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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