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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 K202580
Device Name Disposable Surgical Mask
Applicant
Qingdao Likangyuan Medical Device Co., Ltd.
# 257 Leigongshan Rd., Huangdao District
Qingdao,  CN 266423
Applicant Contact Ying Xu
Correspondent
Wenzhou Cytech Information Service Co., Ltd.
Rm. 302, Bldg. 3, Hangqian Mansion
Hangqian St., Lucheng District
Wenzhou,  CN 325000
Correspondent Contact Helen Nan
Regulation Number878.4040
Classification Product Code
FXX  
Date Received09/08/2020
Decision Date 06/07/2021
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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