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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Suture, Surgical, Absorbable, Polydioxanone
510(k) Number K254238
Device Name MINT MONO Sutures
Applicant
Hans Biomed Corporation
64, Yuseong-Daero 1628 Beon-Gil
Yuseong-Gu,  KR 34054
Applicant Contact Mark Bae
Correspondent
Emergo by UL
2500 Bee Caves Rd.
Bldg. 1, Suite 300
Austin,  TX  78746
Correspondent Contact Sarah Fitzgerald
Regulation Number878.4840
Classification Product Code
NEW  
Date Received12/29/2025
Decision Date 09/18/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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