FDA 510(k) Application Details - K243149

Device Classification Name	More FDA Info for this Device
510(K) Number	K243149
Device Name	Microliter Dosing Syringe (9, 20, 25, 37.5, 50 and 100 microliter models)
Applicant	Congruence Medical Solutions, LLC 3000 Falls Road Suite 200A Baltimore, MD 21211 US Other 510(k) Applications for this Company
Contact	Gautam Shetty Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QLY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/30/2024
Decision Date	12/20/2024
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