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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, I.V. Fluid Transfer
510(k) Number K070584
Device Name SMART-ROD
Applicant
Duoject Medical Systems, Inc.
50 Chemin De Gaspe Complex B-5
Bromont, Qc,  CA J2L 2N8
Applicant Contact CAROLINE LAVOIE
Correspondent
Duoject Medical Systems, Inc.
50 Chemin De Gaspe Complex B-5
Bromont, Qc,  CA J2L 2N8
Correspondent Contact CAROLINE LAVOIE
Regulation Number880.5440
Classification Product Code
LHI  
Date Received03/01/2007
Decision Date 04/02/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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