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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bronchoscope (Flexible Or Rigid)
510(k) Number K231521
Device Name Broncho Videoscope System
Applicant
Scivita Medical Technology Co., Ltd.
#2, Qingqiu St., Suzhou Industrial Park
Suzhou,  CN 215000
Applicant Contact Ruqin Wu
Correspondent
Mid-Link Consulting Co, Ltd.
P.O. Box 120-119
Shanghai,  CN 200120
Correspondent Contact Diana Hong
Regulation Number874.4680
Classification Product Code
EOQ  
Date Received05/26/2023
Decision Date 11/14/2023
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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