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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 K133097
Device Name E-Z LINK
Applicant
Duoject Medical Systems, Inc.
50 Rue De Gaspe Complex B-5
Bromont, Qc.,  CA J2L 2N8
Applicant Contact MARIE-CHRISTINE MESSIER
Correspondent
Duoject Medical Systems, Inc.
50 Rue De Gaspe Complex B-5
Bromont, Qc.,  CA J2L 2N8
Correspondent Contact MARIE-CHRISTINE MESSIER
Regulation Number880.5440
Classification Product Code
LHI  
Date Received09/30/2013
Decision Date 03/13/2014
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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