FDA 510(k) Application Details - K190233

Device Classification Name	Set, Administration, Intravascular   More FDA Info for this Device
510(K) Number	K190233
Device Name	Set, Administration, Intravascular
Applicant	Kawasumi Laboratories, Inc. Shinagawa Intercity Tower B, 9th Floor 2-15-2, Konan, Minato-Ku Tokyo 108-6109 JP Other 510(k) Applications for this Company
Contact	Katsu Furuya 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	02/06/2019
Decision Date	05/02/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review