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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mask, Surgical
510(k) Number K223045
Device Name 3-Ply Disposable Medical Mask
Applicant
Wealth Lead Industrial Limited
2/F, Kras Asia Industrial Bldg., 79 Hung To Rd.
Kwun Tong, Kl
Hong Kong,  CN 0000
Applicant Contact Ethel Chiu Man Mok
Correspondent
Wealth Lead Industrial Limited
2/F, Kras Asia Industrial Bldg., 79 Hung To Rd.
Kwun Tong, Kl
Hong Kong,  CN 0000
Correspondent Contact Ivy Lai
Regulation Number878.4040
Classification Product Code
FXX  
Date Received09/29/2022
Decision Date 12/07/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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