FDA 510(k) Application Details - K040802

Device Classification Name	Thin Layer Chromatography, Propoxyphene   More FDA Info for this Device
510(K) Number	K040802
Device Name	Thin Layer Chromatography, Propoxyphene
Applicant	ARROW INTL., INC. 2400 BERNVILLE RD. READING, PA 19605 US Other 510(k) Applications for this Company
Contact	WILLIAM G MCLAIN Other 510(k) Applications for this Contact
Regulation Number	862.3700   More FDA Info for this Regulation Number
Classification Product Code	DPN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/29/2004
Decision Date	04/28/2004
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	TX - Clinical Toxicology
Review Advisory Committee	TX - Clinical Toxicology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review