FDA 510(k) Application Details - K182765

Device Classification Name	Syringe, Piston   More FDA Info for this Device
510(K) Number	K182765
Device Name	Syringe, Piston
Applicant	TOP Corporation 19-10 Senju Nakai-cho Adachi-ku 120-0035 JP Other 510(k) Applications for this Company
Contact	Sho Yokoya 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	09/28/2018
Decision Date	09/03/2019
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