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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 K992545
Device Name TM-300 TRACTION SYSTEM
Applicant
ITO CO., LTD.
12300 TWINBROOK PKWY.
SUITE 625
rockville,  MD  20852
Applicant Contact t. whit athey
Correspondent
ITO CO., LTD.
12300 TWINBROOK PKWY.
SUITE 625
rockville,  MD  20852
Correspondent Contact t. whit athey
Regulation Number890.5900
Classification Product Code
ITH  
Date Received07/30/1999
Decision Date 09/01/1999
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
Recalls CDRH Recalls
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