FDA 510(k) Application Details - K232543

Device Classification Name	Media, Culture, Ex Vivo, Tissue And Cell   More FDA Info for this Device
510(K) Number	K232543
Device Name	Media, Culture, Ex Vivo, Tissue And Cell
Applicant	Yocon Biology Technology Company 3/F, Bldg. B, No.7, Fengxian Rd. YongFeng Base Haidian District Beijing 100094 CN Other 510(k) Applications for this Company
Contact	Haifeng Li Other 510(k) Applications for this Contact
Regulation Number	876.5885   More FDA Info for this Regulation Number
Classification Product Code	NDS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/22/2023
Decision Date	09/06/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review