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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 K151972
Device Name JUSHA-C43 LCD Monitor
Applicant
Nanjing Jusha Display Technology Co., Ltd.
301, Hnazhongmen St., 8f, # 1
Nanjing International Service Outsourcing
Mansion, Nanjing,  CN 210036
Applicant Contact Ma Jing
Correspondent
Nanjing Jusha Display Technology Co., Ltd.
301, Hnazhongmen St., 8f, # 1
Nanjing International Service Outsourcing
Mansion, Nanjing,  CN 210036
Correspondent Contact Ma Jing
Regulation Number892.2050
Classification Product Code
PGY  
Date Received07/16/2015
Decision Date 09/10/2015
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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