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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Biopsy
510(k) Number K241793
Device Name Automatic Core Biopsy Instrument/ Semi-Automatic Core Biopsy Instrument/ Disposable Coaxial Biopsy Needle
Applicant
Zhejiang Curaway Medical Technology Co., Ltd.
Rm. 106, Bldg. 1, # 600, 21st Ave., Baiyang Sub-District, Qi
Hangzhou,  CN 310018
Applicant Contact Li Yin
Correspondent
Zhejiang Curaway Medical Technology Co., Ltd.
Rm. 106, Bldg. 1, # 600, 21st Ave., Baiyang Sub-District, Qi
Hangzhou,  CN 310018
Correspondent Contact Li Yin
Regulation Number876.1075
Classification Product Code
KNW  
Date Received06/21/2024
Decision Date 01/24/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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