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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 K230093
Device Name Disposable 4 Layers Surgical Face Mask
Applicant
Social Medical Supply, LLC
11528 Harry Hines Blvd. Suite A102
Dallas,  TX  75229
Applicant Contact Shahzil Amin
Correspondent
Guangdong Jianda Medical Technology Co., Ltd.
906 Rm., Longxiang Garden,
Tianhe District
Guangzhou,  CN 510000
Correspondent Contact Jett Lee
Regulation Number878.4040
Classification Product Code
FXX  
Date Received01/12/2023
Decision Date 03/02/2023
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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