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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name tourniquet, pneumatic
510(k) Number K162365
Device Name T-Cuff
Applicant
Terumo BCT, Inc.
10811 W. Collins Ave.
Lakewood,  CO  80215
Applicant Contact Nithya Rajan
Correspondent
Terumo BCT, Inc.
10811 W. Collins Ave.
Lakewood,  CO  80215
Correspondent Contact Nithya Rajan
Regulation Number878.5910
Classification Product Code
KCY  
Date Received08/23/2016
Decision Date 02/16/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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