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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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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