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510(k) K053223

TRITON/TRU-TRAC/TX/TRITON DTS TRACTION by Chattanooga Group — Product Code ITH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 24, 2006
Date Received
November 17, 2005
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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  • K031077 — VECTRA EPR SYSTEM AND INTELECT EPR SYSTEM (December 11, 2003)
  • K031116 — VECTRA (INTELECT) EPR ULTRASOUND (December 3, 2003)
  • K023347 — VITAL STIM (December 6, 2002)

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