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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 K211353
Device Name Medical Face Mask
Applicant
Shenzhen Lyttop Healthcare Limited
A201, building 7, Dongjiu innovation and Technology Park II,
73 Xiali South Road, Longgang District
Shenzhen,  CN 518114
Applicant Contact Lily Wu
Correspondent
Shanghai Sungo Management Consulting Company Limited
14th Floor, 1500# Central Avenue
Shangghai,  CN 200122
Correspondent Contact Ivy Wang
Regulation Number878.4040
Classification Product Code
FXX  
Date Received05/03/2021
Decision Date 08/11/2021
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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