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510(k) K070427

DUPEL TRANSPORT IONTOPHORESIS SYSTEM by Empi — Product Code EGJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 14, 2007
Date Received
February 13, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Iontophoresis, Other Uses
Device Class
Class II
Regulation Number
890.5525
Review Panel
PM
Submission Type

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  • K021100 — 300 PV COMPLETE ELECTROTHERAPY SYSTEM (June 18, 2002)
  • K991991 — DUPEL IONTOPHORESIS SYSTEM (September 10, 1999)
  • K983484 — DUPEL B.L.U.E. SMALL IONTOPHORESIS ELECTRODE (December 28, 1998)

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