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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 K133029
Device Name ABDOMINAL AORTIC AND JUNCTIONAL TOURNIQUET (AAJT) DEVICE
Applicant
Compression Works, LLC
15 Sargent Ave.
Providence,  RI  02906
Applicant Contact MICHAEL FORSTADT
Correspondent
Compression Works, LLC
15 Sargent Ave.
Providence,  RI  02906
Correspondent Contact MICHAEL FORSTADT
Regulation Number870.4450
Classification Product Code
DXC  
Date Received09/26/2013
Decision Date 12/06/2013
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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