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510(k) K101889

DECOMPRESSION OF CHOICE AND NEURO DECOMPRESSION DEVICE by Pivotal Health Solutions — Product Code ITH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 27, 2010
Date Received
July 7, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

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

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