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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Media, Coupling, Ultrasound
510(k) Number K232957
Device Name Sterile and Non-Sterile Ultrasound Gels
Applicant
Jianerkang Medical Co., Ltd.
#1,Jianerkang Rd.,
Zhixi Town Industrial Zone Jintan District
Changzhou,  CN 213251
Applicant Contact Zhang Zhigang
Correspondent
Suzhou Device Innovation Medical Consulting Co., Ltd.
Rm. 1001, Bldg. 19, # 3188 Renmin Rd.
Suzhou,  CN 215000
Correspondent Contact Gu Mike
Regulation Number892.1570
Classification Product Code
MUI  
Date Received09/21/2023
Decision Date 12/15/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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