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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 K230395
Device Name Durio Surgical Face Mask, Models 501 (3-ply, blue) and 545 (4-ply,blue)
Applicant
DURIO PPE SDN BHD
16, Jalan Temenggong
Johor Bahru,  MY 81100
Applicant Contact Xavier Kong
Correspondent
Emergo by UL
2500 Bee Caves Rd., Bldg. 1, Ste. 300
Austin,  TX  78746
Correspondent Contact Sarah Marie Fitzgerald
Regulation Number878.4040
Classification Product Code
FXX  
Date Received02/14/2023
Decision Date 07/17/2023
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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