FDA 510(k) Application Details - K971763

Device Classification Name	Needle, Hypodermic, Single Lumen   More FDA Info for this Device
510(K) Number	K971763
Device Name	Needle, Hypodermic, Single Lumen
Applicant	RETRACTABLE TECHNOLOGIES, INC. 511 LOBO LANE, P.O. BOX 9 LITTLE ELM, TX 75068-0009 US Other 510(k) Applications for this Company
Contact	TERANCE GRISSO 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	05/13/1997
Decision Date	08/26/1997
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