FDA 510(k) Application Details - K073276

Device Classification Name Device, Iontophoresis, Other Uses

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510(K) Number K073276
Device Name Device, Iontophoresis, Other Uses
Applicant ACCLARENT, INC.
1525-B O'BRIEN DR.
MENLO PARK, CA 94025 US
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Contact KERI YEN
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Regulation Number 890.5525

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Classification Product Code EGJ
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Date Received 11/21/2007
Decision Date 03/05/2008
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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