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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Probe, Blood-Flow, Extravascular
510(k) Number K233076
Device Name Laser Speckle Imaging System (RFLSI CZW)
Applicant
Rwd Life Science Co., Ltd.
19f, Bldg. 9a, Vanke Cloud City Iii, Liuxin 4 St.,
Nanshan District
Shenzhen,  CN 518000
Applicant Contact Xuhong Wang
Correspondent
Pureid Medical Technology Co., Ltd.
Guangzhou International Biology Island Luoxuan Blvd. Guanzho
Life Science Innovation Center, Bd.A 3301-3310 & 3316-3318
Guangzhou,  CN
Correspondent Contact Eleanor Wu
Regulation Number870.2120
Classification Product Code
DPT  
Date Received09/26/2023
Decision Date 05/28/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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