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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 K150842
Device Name JUSHA-M53 Medical Display
Applicant
Nanjing Jusha Display Technology Co., Ltd.
301, Hanzhongmen St., 8f Block A, #1
Nanjing,  CN 210036
Applicant Contact JING MA
Correspondent
Guangzhou Osmunda Medical Device Technical Services., Ltd.
7th Floor, Jingui Business Bldg., # 982 Congyun Rd.,
Baiyun District
Guangzhou,  CN 510420
Correspondent Contact Mike Gu
Regulation Number892.2050
Classification Product Code
PGY  
Date Received03/30/2015
Decision Date 04/28/2015
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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