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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 K001296
Device Name SPINAL CORD AND IMMOBILIZATION TRACTION SYSTEM
Applicant
Cavendish Scott, Inc.
Products Division
7301 S. Peoria
Englewood,  CO  80111
Applicant Contact PAUL TRESE
Correspondent
Cavendish Scott, Inc.
Products Division
7301 S. Peoria
Englewood,  CO  80111
Correspondent Contact PAUL TRESE
Regulation Number890.5900
Classification Product Code
ITH  
Subsequent Product Code
INT  
Date Received04/24/2000
Decision Date 07/17/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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