FDA 510(k) Application Details - K030857

Device Classification Name Nasopharyngoscope (Flexible Or Rigid)

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510(K) Number K030857
Device Name Nasopharyngoscope (Flexible Or Rigid)
Applicant MAHE INTL., INC.
490 CRAIGHEAD
NASHVILLE, TN 37204 US
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Contact PAUL CART
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Regulation Number 874.4760

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Classification Product Code EOB
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Date Received 03/18/2003
Decision Date 10/16/2003
Decision SESE - SUBST EQUIV
Classification Advisory Committee EN - Ear, Nose, & Throat
Review Advisory Committee EN - Ear, Nose, & Throat
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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