FDA 510(k) Application Details - K190427

Device Classification Name	Syringe, Piston   More FDA Info for this Device
510(K) Number	K190427
Device Name	Syringe, Piston
Applicant	Terumo Corporation 44-1, 2-Chome, Hatagaya Shibuya-Ku 151-0072 JP Other 510(k) Applications for this Company
Contact	Rudima L Jackson Other 510(k) Applications for this Contact
Regulation Number	880.5860   More FDA Info for this Regulation Number
Classification Product Code	FMF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/22/2019
Decision Date	07/18/2019
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