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510(k) K072946

HYBRESIS IONTOPHORESIS DRUG DELIVERY SYSTEM by Empi — Product Code EGJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 16, 2007
Date Received
October 17, 2007
Clearance Type
Special
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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  • K991991 — DUPEL IONTOPHORESIS SYSTEM (September 10, 1999)
  • K983484 — DUPEL B.L.U.E. SMALL IONTOPHORESIS ELECTRODE (December 28, 1998)

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