FDA 510(k) Application Details - K102192

Device Classification Name	Syringe, Piston   More FDA Info for this Device
510(K) Number	K102192
Device Name	Syringe, Piston
Applicant	BAYLIS MEDICAL CO., INC. 2645 MATHESON BLVD. E MISSISSAUGA, ONTARIO L4W 5S4 CA Other 510(k) Applications for this Company
Contact	MEGHAL KHAKHAR 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	08/04/2010
Decision Date	02/23/2011
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