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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 K030739
Device Name INFUSION DYNAMICS (ID) POWER INFUSER, MODEL M100B-3A WITH BLOOD CARTRIDGE
Applicant
INFUSION DYNAMICS, INC.
5340 SPECTRUM DRIVE, SUITE N
FREDERICK,  MD  21703
Applicant Contact THOMAS BECZE
Correspondent
INFUSION DYNAMICS, INC.
5340 SPECTRUM DRIVE, SUITE N
FREDERICK,  MD  21703
Correspondent Contact THOMAS BECZE
Regulation Number880.5725
Classification Product Code
FRN  
Date Received03/10/2003
Decision Date 01/14/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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