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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 K123694
Device Name SAM JUNCTIONAL TOURNIQUET
Applicant
Sam Medical Products
27350 SW 95th Ave. Suite 3038 Bldg. 30
Wilsonville,  OR  97070
Applicant Contact JACK N MCCUTCHEON
Correspondent
Sam Medical Products
27350 SW 95th Ave. Suite 3038 Bldg. 30
Wilsonville,  OR  97070
Correspondent Contact JACK N MCCUTCHEON
Regulation Number870.4450
Classification Product Code
DXC  
Date Received12/03/2012
Decision Date 03/07/2013
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
Recalls CDRH Recalls
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