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510(k) K992545

TM-300 TRACTION SYSTEM by Ito Co., Ltd. — Product Code ITH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 1, 1999
Date Received
July 30, 1999
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

Other clearances by Ito Co., Ltd.

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  • K081247 — TM-400 (August 25, 2008)
  • K032793 — US-100 PORTABLE ULTRASOUND THERAPY UNIT (October 9, 2003)
  • K022846 — SW-180 SHORTWAVE THERAPY UNIT (January 28, 2003)
  • K990787 — TRIO 300 (October 20, 1999)

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