FDA 510(k) Application Details - K050972

Device Classification Name Nasopharyngoscope (Flexible Or Rigid)

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510(K) Number K050972
Device Name Nasopharyngoscope (Flexible Or Rigid)
Applicant VISION-SCIENCES, INC.
5 WHITCOMB AVE.
AYER, MA 01432 US
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Contact PAMELA PAPINEAU
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Regulation Number 874.4760

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Classification Product Code EOB
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Date Received 04/18/2005
Decision Date 04/29/2005
Decision SESE - SUBST EQUIV
Classification Advisory Committee EN - Ear, Nose, & Throat
Review Advisory Committee EN - Ear, Nose, & Throat
Statement / Summary / Purged Status Statement
Type Special
Reviewed By Third Party N
Expedited Review



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