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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 K991931
Device Name CTD MARK I TRACTION DEVICE
Applicant
Therasys, Inc.
2295 N. Moraine Dr.
Moraine,  OH  45439
Applicant Contact EARNIE S PHILPOT
Correspondent
Therasys, Inc.
2295 N. Moraine Dr.
Moraine,  OH  45439
Correspondent Contact EARNIE S PHILPOT
Regulation Number890.5900
Classification Product Code
ITH  
Date Received06/08/1999
Decision Date 08/12/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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