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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 K221008
Device Name HDR Sensor- HDR361 (Size 1), HDR Sensor- HDR461 (Size 2)
Applicant
Shanghai Handy Medical Equipment Co., Ltd
Floor 2, Building No. 11, Lane177, Fulian Er Road
Baoshan District,  CN 201906
Applicant Contact Marcia Qiu
Correspondent
510K FDA Inc.
100 E Granada Blvd, Suite 219
Ormond Beach,  FL  32176
Correspondent Contact W. Lee Strong
Regulation Number872.1800
Classification Product Code
MUH  
Date Received04/05/2022
Decision Date 06/22/2022
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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