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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Esophageal
510(k) Number K182910
Device Name Segmented Esophageal Stent System
Applicant
Micro-Tech (Nanjing) Co., Ltd.
#10 Gaoke Third Rd.
Nanjing,  CN 210032
Applicant Contact Becky Li
Correspondent
Micro-Tech (Nanjing) Co., Ltd.
#10 Gaoke Third Rd.
Nanjing,  CN 210032
Correspondent Contact Becky Li
Regulation Number878.3610
Classification Product Code
ESW  
Date Received10/17/2018
Decision Date 05/29/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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