FDA 510(k) Application Details - K052019

Device Classification Name Device, Iontophoresis, Other Uses

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510(K) Number K052019
Device Name Device, Iontophoresis, Other Uses
Applicant NORTH COAST MEDICAL, INC.
18305 SUTTER BLVD.
MORGAN HILL, CA 95037-2845 US
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Contact TARHAN KAYIHAN
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Regulation Number 890.5525

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Classification Product Code EGJ
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Date Received 07/26/2005
Decision Date 11/04/2005
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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