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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Extraoral Source, Digital
510(k) Number K192766
Device Name Digital Intraoral Imaging Plate System
Applicant
Fsusen Technology Co., Ltd.
1f, 3# Bldg., Tongfuyu Industrial Zone, Taoyuan St.,
Nanshan District
Shenzhen,  CN 518055
Applicant Contact Elsa Li
Correspondent
Fsusen Technology Co., Ltd.
1f, 3# Bldg., Tongfuyu Industrial Zone, Taoyuan St.,
Nanshan District
Shenzhen,  CN 518055
Correspondent Contact Elsa Li
Regulation Number872.1800
Classification Product Code
MUH  
Date Received09/30/2019
Decision Date 12/05/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Radiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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