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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Display, Diagnostic Radiology
510(k) Number K183499
Device Name JUSHA-M350G/JUSHA-M350/M350G/M350 LCD Monitor
Applicant
Nanjing Jusha Display Technology Co., Ltd
Suite A, 8/F, Bldg 1, No. 301, Hanzhongmen St.
Nanjing,  CN 210036
Applicant Contact Zilong Liang
Correspondent
Nanjing Jusha Display Technology Co., Ltd
Suite A, 8/F, Bldg 1, No. 301, Hanzhongmen St.
Nanjing,  CN 210036
Correspondent Contact Zilong Liang
Regulation Number892.2050
Classification Product Code
PGY  
Date Received12/17/2018
Decision Date 02/04/2019
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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