FDA 510(k) Application Details - K201816

Device Classification Name	Syringe, Piston   More FDA Info for this Device
510(K) Number	K201816
Device Name	Syringe, Piston
Applicant	Accuro Technologies Inc. 201-2067 Cadboro Bay Rd Victoria V8R 5G4 CA Other 510(k) Applications for this Company
Contact	Michael Dolphin 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	07/01/2020
Decision Date	10/16/2020
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