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FDA 510(k), K161298, ShenDa Sinuscope
FDA 510(k), K161298, ShenDa Sinuscope
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510(K) Number: K161298
Device Name: ShenDa Sinuscope
Manufacturer: SHENYANG SHENDA ENDOSCOPE CO., LTD
Device Classification Name: nasopharyngoscope (flexible or rigid)
Regulation Number: 874.4760
Classification Product Code: EOB
Date Received: 05/09/2016
Decision Date: 08/25/2017
Regulation Medical Specialty: Ear Nose & Throat
Device Name: ShenDa Sinuscope
Manufacturer: SHENYANG SHENDA ENDOSCOPE CO., LTD
Device Classification Name: nasopharyngoscope (flexible or rigid)
Regulation Number: 874.4760
Classification Product Code: EOB
Date Received: 05/09/2016
Decision Date: 08/25/2017
Regulation Medical Specialty: Ear Nose & Throat
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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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