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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Transcutaneous Electrical, Aesthetic Purposes
510(k) Number K233010
Device Name Beagank 4T Plus
Applicant
Belega Inc.
1-4-20 Sonezaki Shinchi
Kita-Ku,  JP 530-0002
Applicant Contact Masayuki Okumura
Correspondent
Ken Block Consulting Co., Ltd.
1-9-9 Tsukiji
Chuo-ku,  JP 104-0045
Correspondent Contact Nana Nagashita
Regulation Number882.5890
Classification Product Code
NFO  
Date Received09/22/2023
Decision Date 11/21/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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