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FDA 510(k), K162916, 3NT endoscopy system
FDA 510(k), K162916, 3NT endoscopy system
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510(K) Number: K162916
Device Name: 3NT endoscopy system
Manufacturer: Ehud Bendory
Device Classification Name: Nasopharyngoscope (Flexible Or Rigid)
Regulation Number: EOB
Classification Product Code: KXA
Date Received: 10/17/2016
Decision Date: 02/24/2017
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Ear Nose & Throat
Device Name: 3NT endoscopy system
Manufacturer: Ehud Bendory
Device Classification Name: Nasopharyngoscope (Flexible Or Rigid)
Regulation Number: EOB
Classification Product Code: KXA
Date Received: 10/17/2016
Decision Date: 02/24/2017
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Ear Nose & Throat
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- 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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