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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
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