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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 AVENUE, UNIT #9
huntington beach,  CA  92648
Applicant Contact donald w meyer
Correspondent
CIRCULAR TRACTION SUPPLY, INC.
7602 TALBERT AVENUE, 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
Recalls CDRH Recalls
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