FDA 510(k) Application Details - K172957

Device Classification Name	Set, Transfer (Blood/Plasma)   More FDA Info for this Device
510(K) Number	K172957
Device Name	Set, Transfer (Blood/Plasma)
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	Takayuki Nakajima Other 510(k) Applications for this Contact
Regulation Number	864.9875   More FDA Info for this Regulation Number
Classification Product Code	KSB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/26/2017
Decision Date	09/28/2018
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review