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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 K201718
Device Name GD Disposable Medical Face Mask
Applicant
Jiangsu Guangda Medical Material Group Co., Ltd.
# 18 Baochang Rd. (North)
Libao Town,  CN
Applicant Contact George Zhang
Correspondent
Rogers Consulting
11110 Arranmore Cove
Roanoke,  IN  46783
Correspondent Contact W. Victoria Rogers
Regulation Number878.4040
Classification Product Code
FXX  
Date Received06/23/2020
Decision Date 04/15/2021
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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