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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 K072064
Device Name GRAVILAX TRACTION SYSTEM
Applicant
THERAPEUTIC CLINICAL TECHNOLOGIES, INC.
5335 WISCONSIN AVE., SUITE 440
WASHINGTON,  DC  20016
Applicant Contact DANIEL J MANELLI
Correspondent
THERAPEUTIC CLINICAL TECHNOLOGIES, INC.
5335 WISCONSIN AVE., SUITE 440
WASHINGTON,  DC  20016
Correspondent Contact DANIEL J MANELLI
Regulation Number890.5900
Classification Product Code
ITH  
Date Received07/27/2007
Decision Date 04/21/2008
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
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