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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 K253398
Device Name Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300)
Applicant
Efofex, Inc.
1300 N Dixieland Rd.
Rogers,  AR  72756
Applicant Contact Siddhant Doshi
Correspondent
Mdi Consultants, Inc.
55 Northern Blvd., Suite 200
Great Neck,  NY  11021
Correspondent Contact Vaibhav Rajal
Regulation Number878.4040
Classification Product Code
FXX  
Date Received09/30/2025
Decision Date 02/19/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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