FDA 510(k) Application Details - K170285

Device Classification Name Nasopharyngoscope (Flexible Or Rigid)

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510(K) Number K170285
Device Name Nasopharyngoscope (Flexible Or Rigid)
Applicant National Advanced Endoscopy Devices, Inc.
22134 Sherman Way
Canoga Park, CA 91303 US
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Contact Gayle Butler
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Regulation Number 874.4760

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Classification Product Code EOB
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Date Received 01/30/2017
Decision Date 08/01/2017
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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