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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lithotriptor, Electro-Hydraulic
510(k) Number K243032
Device Name EHL Probe (SCDG-AS); EHL Probe (SCDG-BS); EHL Probe (SCDG-CS)
Applicant
Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.
Rm. 603, Bldg. C2, Innovation Bldg., # 182
Science Ave., Huangpu District
Guangzhou,  CN 510000
Applicant Contact Zhengzhou Li
Correspondent
Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.
Rm.5002-5003, A01 Bldg, Ping'An Tech. Guigu Industrial Park
#74 Chuangyu Rd., Ningxi St., Zengcheng District
Guangzhou,  CN 510000
Correspondent Contact Zhengzhou Li
Regulation Number876.4480
Classification Product Code
FFK  
Date Received09/27/2024
Decision Date 03/21/2025
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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