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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 K001712
Device Name 3D ACTIVETRAC
Applicant
THE SAUNDERS GROUP
4250 NOREX DR.
CHASKA,  MN  55318 -3047
Applicant Contact DOUGLAS G TOMASKO
Correspondent
THE SAUNDERS GROUP
4250 NOREX DR.
CHASKA,  MN  55318 -3047
Correspondent Contact DOUGLAS G TOMASKO
Regulation Number890.5900
Classification Product Code
ITH  
Date Received06/05/2000
Decision Date 08/31/2000
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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