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510(k) K130249

INTEGRITY SPINAL CARE SYSTEM 3.0 by Integrity Life Sciences — Product Code ITH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 6, 2014
Date Received
February 1, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Equipment, Traction, Powered
Device Class
Class II
Regulation Number
890.5900
Review Panel
PM
Submission Type

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