FDA 510(k) Application Details - K110687

Device Classification Name Cannula, Sinus

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510(K) Number K110687
Device Name Cannula, Sinus
Applicant ACCLARENT, INC.
1525-B O'BRIEN DR.
MENLO PARK, CA 94025 US
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Contact DEAN KNIGHT
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Regulation Number 878.4800

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Classification Product Code KAM
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Date Received 03/11/2011
Decision Date 10/07/2011
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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