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510(k) K073542

CYCLETRAC CT-5000 by Pt Products, LLC — Product Code ITH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 14, 2008
Date Received
December 17, 2007
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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