FDA 510(k) Application Details - K061522

Device Classification Name Device, Iontophoresis, Other Uses

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510(K) Number K061522
Device Name Device, Iontophoresis, Other Uses
Applicant ACTIVA TEK INC
340 BROADWAY CENTRE
111 EAST BROADWAY
SALT LAKE CITY, UT 84111 US
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Contact DAVID SCOFIELD
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Regulation Number 890.5525

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Classification Product Code EGJ
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Date Received 06/02/2006
Decision Date 08/01/2006
Decision SESE - SUBST EQUIV
Classification Advisory Committee PM - Physical Medicine
Review Advisory Committee PM - Physical Medicine
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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