FDA 510(k) Application Details - K041590

Device Classification Name	Syringe, Piston   More FDA Info for this Device
510(K) Number	K041590
Device Name	Syringe, Piston
Applicant	INDIGO ORB, INC. 2355 CALLE DE LUNA SANTA CLARA, CA 95054 US Other 510(k) Applications for this Company
Contact	ROBERT CHIN 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	06/14/2004
Decision Date	06/23/2004
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	Y
Expedited Review