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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 K252021
Device Name Disposable Endoscopic Injection Needles
Applicant
Changzhou New Med Micro-Medtech Co., Ltd.
# 99 Of Longxi Ave., Zhulin Town, Jintan District,
Changzhou,  CN
Applicant Contact Ashe Chen
Correspondent
Landlink Healthcare Technology (Shanghai) Co., Ltd.
Rm. 1308, Baohua International Plz.
West Guangzhong Rd. 555, Jingan District
Shanghai,  CN
Correspondent Contact Kyra Kang
Regulation Number876.1500
Classification Product Code
FBK  
Date Received06/30/2025
Decision Date 12/02/2025
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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