FDA 510(k) Application Details - K250138

Device Classification Name	More FDA Info for this Device
510(K) Number	K250138
Device Name	Small Volume 0.2mL Syringe
Applicant	Prosum Medical Limited Unit 14 Trade City Business Park, Cowley Mill Road Uxbridge UB8 2DB GB Other 510(k) Applications for this Company
Contact	Yanshen Sun Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QNQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/17/2025
Decision Date	04/02/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review