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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 K254060
Device Name Life Saving Tourniquet
Applicant
TW Medical
149 Revava St.
Otniel,  IL 9040700
Applicant Contact Yaakov Tsadik
Correspondent
Rook Quality Systems
1155 Mount Vernon Hwy.
Dunwody,  GA  30338
Correspondent Contact Tyler Ting
Regulation Number870.4450
Classification Product Code
DXC  
Date Received12/17/2025
Decision Date 04/03/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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