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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 K032449
Device Name THERMASSAGE ENERGY PRODUCT, MODEL HY5000
Applicant
MIGUN MEDICAL INSTRUMENT CO. LTD.
5905 FAWN LANE
CLEVELAND,  OH  44141
Applicant Contact EDWARD A KROLL
Correspondent
MIGUN MEDICAL INSTRUMENT CO. LTD.
5905 FAWN LANE
CLEVELAND,  OH  44141
Correspondent Contact EDWARD A KROLL
Regulation Number890.5880
Classification Product Code
JFB  
Subsequent Product Code
ILY  
Date Received08/08/2003
Decision Date 10/22/2003
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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