FDA 510(k) Application Details - K132039

Device Classification Name Laryngoscope, Nasopharyngoscope

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510(K) Number K132039
Device Name Laryngoscope, Nasopharyngoscope
Applicant JEDMED INSTRUMENT CO.
5416 JEDMED CT.
ST. LOUIS, MO 63129-2221 US
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Contact CRAIG PARKS
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Regulation Number 874.4760

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Classification Product Code EQN
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Date Received 07/02/2013
Decision Date 02/21/2014
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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