FDA 510(k), K170285, AED Sinuscope

FDA 510(k), K170285, AED Sinuscope

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510(K) Number: K170285
Device Name: AED Sinuscope
Manufacturer: National Advanced Endoscopy Devices, Inc.
Device Classification Name: Nasopharyngoscope (Flexible Or Rigid)
Regulation Number: 874.4760
Classification Product Code: EOB
Date Received: 01/30/2017
Decision Date: 08/01/2017
Regulation Medical Specialty: Ear Nose & Throat

  • Status: Pending Fast-Track Request
  • Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity

NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.

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