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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, X-Ray, Extraoral With Timer
510(k) Number K232068
Device Name HyperLight Portable X-ray Unit
Applicant
Changzhou Sifary Medical Technology Co., Ltd.
#99 Qingyang Rd., Xuejia County, Xinbei District
Changzhou,  CN 213000
Applicant Contact Tao Huan
Correspondent
510K FDA, Inc.
156 E. Granada Blvd.
Ormond Beach,  FL  32176
Correspondent Contact W. Lee Strong
Regulation Number872.1800
Classification Product Code
EHD  
Date Received07/12/2023
Decision Date 09/01/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
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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