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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sleeve, Limb, Compressible
510(k) Number K254267
Device Name NanoPress 760A-BT (760A-BT)
Applicant
Mego Afek , Ltd.
Kibbuts Afek
Kibbuts Afek,  IL 3004200
Applicant Contact Reuven Yunger
Correspondent
Ilan Sharon MD Consultant
P.O.Box 4414 (A109)
Caesarea,  IL 3088900
Correspondent Contact Ilan Sharon
Regulation Number870.5800
Classification Product Code
JOW  
Date Received12/30/2025
Decision Date 02/24/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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