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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Clamp, Vascular
510(k) Number K150813
Device Name iTClamp50
Applicant
Innovative Trauma Care, Inc.
3463 Magic Dr., Suite 120
San Antonio,  TX  78229
Applicant Contact Ian Atkinson
Correspondent
Innovative Trauma Care, Inc.
3463 Magic Dr., Suite 120
San Antonio,  TX  78229
Correspondent Contact Ian Atkinson
Regulation Number870.4450
Classification Product Code
DXC  
Date Received03/27/2015
Decision Date 04/30/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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