FDA 510(k) Application Details - K003193

Device Classification Name	Syringe, Piston   More FDA Info for this Device
510(K) Number	K003193
Device Name	Syringe, Piston
Applicant	BAXTER HEALTHCARE CORP. 550 NORTH BRAND BLVD. GLENDALE, CA 91023 US Other 510(k) Applications for this Company
Contact	ARLENE VIDOR 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	10/12/2000
Decision Date	11/07/2000
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review