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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.
# 123 Hezuo St., 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
Predetermined Change
Control Plan Authorized		 No
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