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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 K253070
Device Name Namic Radial Arm Band, 23 cm (DYNJRADBAND); Namic Radial Arm Band, 26 cm (DYNJRADBANDL)
Applicant
Medline Industries, LP
Three Lakes Dr.
Nortfield,  IL  60093
Applicant Contact Payal Solanki
Correspondent
Medline Industries, LP
Three Lakes Dr.
Nortfield,  IL  60093
Correspondent Contact Payal Solanki
Regulation Number870.4450
Classification Product Code
DXC  
Date Received09/23/2025
Decision Date 11/20/2025
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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