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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscopic Access Overtube, Gastroenterology-Urology
510(k) Number K190030
Device Name Embrella Endoscopic Distal Attachment
Applicant
Micro-Tech (Nanjing) Co., Ltd.
NO. 10 Gaoke Third Road
Nanjing,  CN 210032
Applicant Contact Becky Li
Correspondent
Micro-Tech (Nanjing) Co., Ltd.
NO. 10 Gaoke Third Road
Nanjing,  CN 210032
Correspondent Contact Becky Li
Regulation Number876.1500
Classification Product Code
FED  
Date Received01/07/2019
Decision Date 03/05/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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