FDA 510(k) Application Details - K110097

Device Classification Name Nasopharyngoscope (Flexible Or Rigid)

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510(K) Number K110097
Device Name Nasopharyngoscope (Flexible Or Rigid)
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 874.4760

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Classification Product Code EOB
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Date Received 01/13/2011
Decision Date 05/27/2011
Decision SESE - SUBST EQUIV
Classification Advisory Committee EN - Ear, Nose, & Throat
Review Advisory Committee EN - Ear, Nose, & Throat
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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