FDA 510(k) Application Details - K183496

Device Classification Name

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510(K) Number K183496
Device Name JUSHA-C350G LCD Monitor, JUSHA-C350 LCD Monitor, C350G LCD Monitor, C350 LCD Monitor
Applicant Nanjing Jusha Display Technology Co., Ltd
Suite A, 8/F, Bldg 1, No. 301, Hanzhongmen St.
Nanjing 210036 CN
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Contact Zilong Liang
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Regulation Number

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Classification Product Code PGY
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Date Received 12/17/2018
Decision Date 04/08/2019
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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