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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Submucosal Injection Agent
510(k) Number K191254
Device Name EndoClot
Applicant
Endoclot Plus Co., Ltd.
101 Rm., B8 Bldg., 218 Xinghu St.,
Suzhou Industrial Park
Suzhou,  CN 215000
Applicant Contact Hendry Zhang
Correspondent
Medwheat (Shanghai) Medical Technology Co. , Ltd.
Yangpu District Liaoyuan E. Rd. Shuangyang First Suite
# 33 Rm. 303
Shanghai,  CN 200093
Correspondent Contact Jonathan Hu
Regulation Number876.1500
Classification Product Code
PLL  
Date Received05/10/2019
Decision Date 01/30/2020
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
Predetermined Change
Control Plan Authorized		 No
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