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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 K252830
Device Name Disposable Surgical Face Mask (3P00B, C2900)
Applicant
Beatles Medical Supplies (Xiantao) Co., Ltd.
Louhe Industrial Park, Louhe Town
Xiantao,  CN
Applicant Contact Paul Stark
Correspondent
Shanghai SUNGO Management Consulting Co., Ltd.
14th Floor, Dongfang Bldg., 1500# Century Ave.
Shanghai,  CN
Correspondent Contact Kiwi Xu
Regulation Number878.4040
Classification Product Code
FXX  
Date Received09/05/2025
Decision Date 01/12/2026
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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