FDA 510(k) Application Details - K232577

Device Classification Name	Clamp, Vascular   More FDA Info for this Device
510(K) Number	K232577
Device Name	Clamp, Vascular
Applicant	Ningbo DIZEGENS Medical Science Co., Ltd. Floor 3&4, Building A4, No. 777, Binhai 4th Road Qianwan New Area. Ningo, NJ 315336 US Other 510(k) Applications for this Company
Contact	Zhang Wenwei Other 510(k) Applications for this Contact
Regulation Number	870.4450   More FDA Info for this Regulation Number
Classification Product Code	DXC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/25/2023
Decision Date	01/18/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review