FDA 510(k) Application Details - K230668

Device Classification Name	Injector And Syringe, Angiographic   More FDA Info for this Device
510(K) Number	K230668
Device Name	Injector And Syringe, Angiographic
Applicant	Precision Medical Plastics Ltd. 2B1401, Smart Park II, No. 76, Baohe Avenue Baolong Community, Baolong Street, Longgang District Shenzhen 518100 CN Other 510(k) Applications for this Company
Contact	Li Xiaotong Other 510(k) Applications for this Contact
Regulation Number	870.1650   More FDA Info for this Regulation Number
Classification Product Code	DXT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/10/2023
Decision Date	06/14/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review