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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dislodger, Stone, Biliary
510(k) Number K243471
Device Name Extraction Basket
Applicant
Micro-Tech (Nanjing) Co., Ltd.
# 10 Gaoke Third Rd., Nanjing National Hi-Tech Industrial
Development Zone
Nanjing,  CN 210032
Applicant Contact He Sally
Correspondent
Micro-Tech (Nanjing) Co., Ltd.
# 10 Gaoke Third Rd., Nanjing National Hi-Tech Industrial
Development Zone
Nanjing,  CN 210032
Correspondent Contact He Sally
Regulation Number876.5010
Classification Product Code
LQR  
Date Received11/08/2024
Decision Date 12/16/2024
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
Predetermined Change
Control Plan Authorized		 No
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