FDA 510(k) Application Details - K150248

Device Classification Name Laryngoscope, Nasopharyngoscope

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510(K) Number K150248
Device Name Laryngoscope, Nasopharyngoscope
Applicant JEDMED INSTRUMENT COMPANY
5416 JEDMED COURT
ST. LOUIS, MO 63129 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 02/03/2015
Decision Date 07/23/2015
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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