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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 K021988
Device Name MEDRAD CONTINUUM MR COMPATIBLE INFUSION SYSTEM
Applicant
MEDRAD, INC.
ONE MEDRAD DR.
INDIANOLA,  PA  15051
Applicant Contact LORRAINE R FREDES
Correspondent
CITECH
5200 BUTLER PIKE
PLYMOUTH MEETING,  PA  19462 -1298
Correspondent Contact ROBERT MOSENKIS
Regulation Number880.5725
Classification Product Code
FRN  
Subsequent Product Code
FPA  
Date Received06/18/2002
Decision Date 08/29/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Abbreviated
Reviewed by Third Party Yes
Combination Product No
Recalls CDRH Recalls
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