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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscope Channel Accessory
510(k) Number K252933
Device Name DYNE PORT
Applicant
Dyne Medical Group, Inc.
#1001-1013, #1015-1016, #1024-1025, 10f, 165
Gimpohangang 10-Ro 133beon-Gil
Gyeonggi-Do,  KR 10071
Applicant Contact Young-Hoon Moon
Correspondent
Gms Consulting
#B-612, 66 Chengcho-Ro
Gyeonggi-Do,  KR 10543
Correspondent Contact Jonghyeon Kim
Regulation Number876.1500
Classification Product Code
ODC  
Date Received09/15/2025
Decision Date 06/12/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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