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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Table, Physical Therapy, Multi Function
510(k) Number K243355
Device Name Ceragem Automatic Thermal Massager (CGM-MB-1902)
Applicant
Ceragem Co., Ltd.
10, Jeongja 1-Gil, Seonggeo-Eup, Seobuk-Gu
Chennan-Si,  KR 31041
Applicant Contact Choongwoo Lee
Correspondent
Provision Consulting Group, Inc.
13925 City Center Dr. Suite 200
Chino Hills,  CA  91709
Correspondent Contact Joyce Kwon
Regulation Number890.5880
Classification Product Code
JFB  
Date Received10/29/2024
Decision Date 11/27/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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