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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 WEST BUSCH BLVD
tampa,  FL  33612
Applicant Contact james j gibson
Correspondent
INTEGRITY LIFE SCIENCES
2189 WEST 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
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