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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 K202937
Device Name Ceragem Automatic Thermal Massager Model CGM-MB-1701 & CGM-MB-1702
Applicant
Ceragem Co., Ltd.
10, Jeongja 1-Gil, Seonggeo-Eup, Seobuk-Gu
Chennan-Si,  KR 31041
Applicant Contact Hyeonggeun Hwang
Correspondent
LK Consulting Group USA, Inc.
1150 Roosevelt Suite 200
Irvine,  CA  92620
Correspondent Contact Priscilla Chung
Regulation Number890.5880
Classification Product Code
JFB  
Date Received09/30/2020
Decision Date 03/18/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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