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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 K992044
Device Name INFUSION DYNAMICS POWER INFUSER MODEL M100B
Applicant
Infusion Dynamics, Inc.
116 Village Blvd., Suite 200
Princeton,  NJ  08540
Applicant Contact THOMAS BECZE
Correspondent
Infusion Dynamics, Inc.
116 Village Blvd., Suite 200
Princeton,  NJ  08540
Correspondent Contact THOMAS BECZE
Regulation Number880.5725
Classification Product Code
FRN  
Date Received06/17/1999
Decision Date 09/08/1999
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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