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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 K220487
Device Name Disposable Medical Face Mask
Applicant
Hubei Mediunion Medical Products Co., Ltd.
#1 Chuangye Rd., Zhongling Industrial Zone,
Pengchang Town
Xiantao,  CN 433000
Applicant Contact Jason Sheen
Correspondent
Hubei Mediunion Medical Products Co., Ltd.
#1 Chuangye Rd., Zhongling Industrial Zone,
Pengchang Town
Xiantao,  CN 433000
Correspondent Contact Jason Sheen
Regulation Number878.4040
Classification Product Code
FXX  
Date Received02/22/2022
Decision Date 04/26/2022
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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