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510(k) K132832

ACTIVAPATCH ET IONTOPHORESIS PATCH by Activatek, Inc. — Product Code EGJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 13, 2014
Date Received
September 10, 2013
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

Other clearances by Activatek, Inc.

  • K091326 — ACTIVAPATCH (May 27, 2009)
  • K061522 — TRIVARION BUFFERED IONTOPHORESIS ELECTRODE SYSTEM (August 1, 2006)

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