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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 K243627
Device Name Laryngoscope Junctional-Arterial Restriction Clamp (L-ARC); Arterial Restriction Clamp (ARC)
Applicant
Arc Trauma, LLC
2310 Mt. Carmel Rd.
Jamestown,  OH  45335
Applicant Contact Jeffrey Williams
Correspondent
Arc Trauma, LLC
2310 Mt. Carmel Rd.
Jamestown,  OH  45335
Correspondent Contact Jeffrey Williams
Regulation Number870.4450
Classification Product Code
DXC  
Subsequent Product Code
CCW  
Date Received11/25/2024
Decision Date 12/31/2025
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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