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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 K213617
Device Name Surgical Face Mask
Applicant
Megasoft (China) Co., Ltd.
No.1 Xinqiang Road, Machinery Printing Base,
Gaoxin District, HongShan Town
Shishi,  CN
Applicant Contact Sarah Qiu
Correspondent
Shanghai Sungo Management Consulting Company Limited
14th Floor, 1500# Central Avenue
Shanghai,  CN 200122
Correspondent Contact Ivy Wang
Regulation Number878.4040
Classification Product Code
FXX  
Date Received11/15/2021
Decision Date 02/11/2022
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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