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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ultrasound Guided Nerve Block Assist
510(k) Number K250818
Device Name Nerveblox
Applicant
Smart Alfa Teknoloji San. Ve Tic. A.S.
Universiteler Mah. Ihsan Dogramaci Blv
No:17-1 #109, Cankaya
Ankara,  TR 06800
Applicant Contact Utku Kaya
Correspondent
Smart Alfa Teknoloji San. Ve Tic. A.S.
Universiteler Mah. Ihsan Dogramaci Blv
No:17-1 #109, Cankaya
Ankara,  TR 06800
Correspondent Contact Utku Kaya
Classification Product Code
QRG  
Date Received03/18/2025
Decision Date 08/15/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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