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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 K231155
Device Name Biodegradable Medical surgical mask
Applicant
Guangdong Kingfa Sci. & Tech.Co., Ltd.
# 28 Delong Ave., Shijiao Town, Qingcheng District
Qingyuan,  CN 511545
Applicant Contact Xiaoge Yu
Correspondent
Guangdong Kingfa Sci. & Tech.Co., Ltd.
# 28 Delong Ave., Shijiao Town, Qingcheng District
Qingyuan,  CN 511545
Correspondent Contact Xiaoge Yu
Regulation Number878.4040
Classification Product Code
FXX  
Date Received04/24/2023
Decision Date 11/07/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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