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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 K010703
Device Name INTER-VIAL
Applicant
Duoject Medical Systems, Inc.
50 Rue De Gaspe Complex B-5
Bromont, Qc.,  CA J2L 2N8
Applicant Contact DANIEL MACDONALD
Correspondent
Duoject Medical Systems, Inc.
50 Rue De Gaspe Complex B-5
Bromont, Qc.,  CA J2L 2N8
Correspondent Contact DANIEL MACDONALD
Regulation Number880.5440
Classification Product Code
LHI  
Date Received03/09/2001
Decision Date 06/25/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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