FDA 510(k) Application Details - K202279

Device Classification Name	Set, Administration, Intravascular   More FDA Info for this Device
510(K) Number	K202279
Device Name	Set, Administration, Intravascular
Applicant	Innovative Health Sciences, LLC 1108 Kings Highway, Suite 4 Chester, NY 10918 US Other 510(k) Applications for this Company
Contact	Andy Sealfon Other 510(k) Applications for this Contact
Regulation Number	880.5440   More FDA Info for this Regulation Number
Classification Product Code	FPA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/11/2020
Decision Date	08/13/2021
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