FDA 510(k) Application Details - K231633

Device Classification Name	More FDA Info for this Device
510(K) Number	K231633
Device Name	Disposable Hemoclip (AF series)
Applicant	Alton (Shanghai) Medical Instruments Co. Ltd No.24 Building Jinshao Rd.1688. Baoshan District.200949. Shanghai. China Shanghai 200949 CN Other 510(k) Applications for this Company
Contact	Vivian Li Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PKL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/05/2023
Decision Date	01/11/2024
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