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510(k) K081247

TM-400 by Ito Co., Ltd. — Product Code ITH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 25, 2008
Date Received
May 1, 2008
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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  • K992545 — TM-300 TRACTION SYSTEM (September 1, 1999)

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