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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Laparoscopic Single Port Access Device
510(k) Number K232062
Device Name Uni-port
Applicant
Dalim Medical Corp.
102-606 and 609(Ho), 397, Seokcheon-ro
Bucheon-si,  KR 14449
Applicant Contact Ji Hoon Eom
Correspondent
Dalim Medical Corp.
102-606 and 609(Ho), 397, Seokcheon-ro
Bucheon-si,  KR 14449
Correspondent Contact Dave Kim
Regulation Number876.1500
Classification Product Code
OTJ  
Date Received07/11/2023
Decision Date 01/16/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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