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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 K112384
Device Name ABDOMINAL TOURNIQUET SYSTEM
Applicant
COMPRESSION WORKS LLC
15 SARGENT AVE
PROVIDENCE,  RI  02906
Applicant Contact Ruth Forstadt
Correspondent
COMPRESSION WORKS LLC
15 SARGENT AVE
PROVIDENCE,  RI  02906
Correspondent Contact Ruth Forstadt
Regulation Number870.4450
Classification Product Code
DXC  
Date Received08/18/2011
Decision Date 10/18/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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