FDA 510(k) Application Details - K980069

Device Classification Name	Syringe, Antistick   More FDA Info for this Device
510(K) Number	K980069
Device Name	Syringe, Antistick
Applicant	RETRACTABLE TECHNOLOGIES, INC. 511 LOBO LN. 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	880.5860   More FDA Info for this Regulation Number
Classification Product Code	MEG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/08/1998
Decision Date	02/12/1998
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