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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscope, General & Plastic Surgery
510(k) Number K190831
Device Name E240AG LCD Monitor, E240A LCD Monitor, JUSHA-E240AG LCD Monitor, JUJSHA-E240A LCD Monitor, C230A LCD Monitor, JUSHA-C230A LCD Monitor, C230M LCD Monitor, JUSHA-C230M LCD Monitor
Applicant
Nanjing Jusha Display Technology Co., Ltd.
Suite A, 8/F, Bldg. 1, # 301, Hanzhongmen St.,
Nanjing,  CN 210036
Applicant Contact Zilong Liang
Correspondent
Nanjing Jusha Display Technology Co., Ltd.
Suite A, 8/F, Bldg. 1, # 301, Hanzhongmen St.,
Nanjing,  CN 210036
Correspondent Contact Zilong Liang
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received04/01/2019
Decision Date 05/31/2019
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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