FDA 510(k) Application Details - K992626

Device Classification Name	Needle, Hypodermic, Single Lumen   More FDA Info for this Device
510(K) Number	K992626
Device Name	Needle, Hypodermic, Single Lumen
Applicant	SURE-WAY SYSTEMS, INC. 310 HARRY BRIDGES BLVD. WILMINGTON, CA 90744 US Other 510(k) Applications for this Company
Contact	GARY CHILCOTT Other 510(k) Applications for this Contact
Regulation Number	880.5570   More FDA Info for this Regulation Number
Classification Product Code	FMI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/05/1999
Decision Date	12/16/1999
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review