FDA 510(k) Application Details - K213429

Device Classification Name	Introducer, Syringe Needle   More FDA Info for this Device
510(K) Number	K213429
Device Name	Introducer, Syringe Needle
Applicant	Emed Technologies Corporation 1262 Hawks Flight Ct, Ste. 200 El Dorado Hills, CA 95762 US Other 510(k) Applications for this Company
Contact	Peter Kollings Other 510(k) Applications for this Contact
Regulation Number	880.6920   More FDA Info for this Regulation Number
Classification Product Code	KZH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/21/2021
Decision Date	10/20/2022
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