FDA 510(k) Application Details - K232062

Device Classification Name	More FDA Info for this Device
510(K) Number	K232062
Device Name	Uni-port
Applicant	Dalim Medical Corp. 102-606 and 609(Ho), 397, Seokcheon-ro Bucheon-si 14449 KR Other 510(k) Applications for this Company
Contact	Ji Hoon Eom Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OTJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/11/2023
Decision Date	01/16/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review