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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscopic Injection Needle, Gastroenterology-Urology
510(k) Number K240675
Device Name Endoscopic Injection Needles
Applicant
Promisemed Hangzhou Meditech Co., Ltd.
No. 1388 Cangxing Street
Cangqian Community, Yuhang District
Hangzhou City,  CN 311121
Applicant Contact Yang Zearou
Correspondent
Promisemed Hangzhou Meditech Co., Ltd.
No. 1388 Cangxing Street
Cangqian Community, Yuhang District
Hangzhou City,  CN 311121
Correspondent Contact Yang Zearou
Regulation Number876.1500
Classification Product Code
FBK  
Date Received03/11/2024
Decision Date 10/04/2024
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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