FDA 510(k), K161298, ShenDa Sinuscope
FDA 510(k), K161298, ShenDa Sinuscope
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
Total pages: 1,410
Fully redacted pages: 888
Content pages: 522
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