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510(k) K092780

INF 4160 PLUS, MODEL D-FJ31F by Fuji Dynamics Limited — Product Code LIH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 7, 2010
Date Received
September 10, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Interferential Current Therapy
Device Class
Class II
Regulation Number
882.5890
Review Panel
NE
Submission Type

Other clearances by Fuji Dynamics Limited

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  • K041164 — L-TENS (May 20, 2004)
  • K994266 — FDTENS 2010 (July 6, 2000)
  • K994265 — MEDISANA DIGITAL TENS (July 6, 2000)

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