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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 K040031
Device Name CERAGEM-C THERMAL ACUPRESSURE MASSAGER
Applicant
Ceragem Co., Ltd.
1800 Massachusetts Ave. NW
Suite 200
Washington,  DC  20036
Applicant Contact SUZAN ONEL
Correspondent
Ceragem Co., Ltd.
1800 Massachusetts Ave. NW
Suite 200
Washington,  DC  20036
Correspondent Contact SUZAN ONEL
Regulation Number890.5880
Classification Product Code
JFB  
Date Received01/08/2004
Decision Date 07/28/2004
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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