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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 K130249
Device Name INTEGRITY SPINAL CARE SYSTEM 3.0
Applicant
Integrity Life Sciences
2189 W.Busch Blvd.
Tampa,  FL  33612
Applicant Contact JAMES J GIBSON
Correspondent
Integrity Life Sciences
2189 W.Busch Blvd.
Tampa,  FL  33612
Correspondent Contact JAMES J GIBSON
Regulation Number890.5900
Classification Product Code
ITH  
Date Received02/01/2013
Decision Date 02/06/2014
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
Predetermined Change
Control Plan Authorized		 No
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