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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name nasopharyngoscope (flexible or rigid)
510(k) Number K161298
Device Name ShenDa Sinuscope
Applicant
SHENYANG SHENDA ENDOSCOPE CO., LTD
NO.123 HEZUO STREET, DADONG DISTRICT
SHENYANG,  CN 110044
Applicant Contact GAO FENG
Correspondent
MID-LINK CONSULTING CO., LTD
P.O. BOX 120-119
SHANGHAI,  CN 200120
Correspondent Contact DIANA HONG
Regulation Number874.4760
Classification Product Code
EOB  
Date Received05/09/2016
Decision Date 08/25/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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