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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 K202598
Device Name 3 Layer Surgical Mask with Ear Loops Level 1, 3 Layer Surgical Mask with Ties Level 1, 3 Layer Surgical Mask with Ear Loops Level 2, 3 Layer Surgical Mask with Ties Level 2, 3 Layer Surgical Mask with Ear Loops Level 3, 3 Layer Surgical Marks with Ties Level 3
Applicant
3A Medical Products Co., Ltd.
Yu An Industrial Park 230001
Liu An,  CN
Applicant Contact Slinda Ma
Correspondent
3A Medical Products Co., Ltd.
Yu An Industrial Park 230001
Liu An,  CN
Correspondent Contact Mary Mejaes
Regulation Number878.4040
Classification Product Code
FXX  
Date Received09/08/2020
Decision Date 05/06/2021
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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