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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Equipment, Traction, Powered
510(k) Number K081247
Device Name TM-400
Applicant
Ito Co., Ltd.
1201 Richardson Dr.
Suite 140
Richardson,  TX  75080
Applicant Contact KENNETH L BLOCK
Correspondent
Ito Co., Ltd.
1201 Richardson Dr.
Suite 140
Richardson,  TX  75080
Correspondent Contact KENNETH L BLOCK
Regulation Number890.5900
Classification Product Code
ITH  
Date Received05/01/2008
Decision Date 08/25/2008
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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