FDA 510(k) Application Details - K072891

Device Classification Name Cannula, Sinus

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510(K) Number K072891
Device Name Cannula, Sinus
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 878.4800

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Classification Product Code KAM
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Date Received 10/10/2007
Decision Date 03/19/2008
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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