FDA 510(k) Application Details - K202688

Device Classification Name	More FDA Info for this Device
510(K) Number	K202688
Device Name	AFS Medical Sterile Single-Use Access Port System
Applicant	AFS Medical Co. Ltd. Na-131, Ezen Mecha Zone, 117 Hwanggeum-ro, Yangchon-eup, Gimpo-si Gyeonggi-do 10048 KR Other 510(k) Applications for this Company
Contact	Min Ah Kim 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	09/15/2020
Decision Date	10/14/2021
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