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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 K101889
Device Name DECOMPRESSION OF CHOICE AND NEURO DECOMPRESSION DEVICE
Applicant
Pivotal Health Solutions
1521 9th Ave. SE Suite 3
Watertown,  SD  57201
Applicant Contact PHILLIP KLEIN
Correspondent
Intertek Testing Services
2307 E. Aurora Rd.
Unit B7
Twinsburg,  OH  44087
Correspondent Contact WILLIAM SAMMONS
Regulation Number890.5900
Classification Product Code
ITH  
Date Received07/07/2010
Decision Date 08/27/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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