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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 K063353
Device Name CTBOX CERVICAL/LUMBAR TRACTION
Applicant
Circular Traction Supply, Inc.
7602 Talbert Ave., Unit #9
Huntington Beach,  CA  92648
Applicant Contact DONALD W MEYER
Correspondent
Circular Traction Supply, Inc.
7602 Talbert Ave., Unit #9
Huntington Beach,  CA  92648
Correspondent Contact DONALD W MEYER
Regulation Number890.5900
Classification Product Code
ITH  
Subsequent Product Codes
ILZ   IRS  
Date Received11/06/2006
Decision Date 03/14/2007
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
Recalls CDRH Recalls
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