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510(k) K071347

VAX-D GENESIS G2 SYSTEM by Vax-D Medical Technologies, LLC — Product Code ITH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 5, 2007
Date Received
May 14, 2007
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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