FDA 510(k) Application Details - K902683

Device Classification Name Nasopharyngoscope (Flexible Or Rigid)

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510(K) Number K902683
Device Name Nasopharyngoscope (Flexible Or Rigid)
Applicant HEALTHTEK MICROSURGICAL, INC.
JEFF MANNI, SUITE 400
6 NEW ENGLAND EXECUTIVE PARK
BURLINGTON, MA US
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Contact JM ASSOCIATES
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Regulation Number 874.4760

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Classification Product Code EOB
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Date Received 06/19/1990
Decision Date 10/31/1990
Decision SE - Substantially Equivalent
Classification Advisory Committee EN - Ear, Nose, & Throat
Review Advisory Committee EN - Ear, Nose, & Throat
Statement / Summary / Purged Status
Type Traditional
Reviewed By Third Party N
Expedited Review



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