FDA 510(k) Application Details - K072654

Device Classification Name	Syringe, Piston   More FDA Info for this Device
510(K) Number	K072654
Device Name	Syringe, Piston
Applicant	RETRACTABLE TECHNOLOGIES, INC. 511 LOBO LN. LITTLE ELM, TX 75068-0009 US Other 510(k) Applications for this Company
Contact	RHONDA WELLS 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	09/20/2007
Decision Date	12/14/2007
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	N
Expedited Review