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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 K211696
Device Name Disposable Surgical Face Mask
Applicant
Anhui Cleanpro Pharmpack Co., Ltd.
Yeshan Industrial Zone
Tianchang,  CN 239300
Applicant Contact Chong Xiuming
Correspondent
Anhui Cleanpro Pharmpack Co., Ltd.
Yeshan Industrial Zone
Tianchang,  CN 239300
Correspondent Contact Chong Xiuming
Regulation Number878.4040
Classification Product Code
FXX  
Date Received06/02/2021
Decision Date 11/30/2021
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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