FDA 510(k) Application Details - K002213

Device Classification Name	Needle, Hypodermic, Single Lumen   More FDA Info for this Device
510(K) Number	K002213
Device Name	Needle, Hypodermic, Single Lumen
Applicant	HUNTER RESEARCH LABORATORIES, INC. 1541 SOUTH VINE ST. DENVER, CO 80210 US Other 510(k) Applications for this Company
Contact	BARBARA PEDIGO 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	07/21/2000
Decision Date	10/03/2000
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