FDA 510(k) Application Details - K021998

Device Classification Name	Endoscopic Cytology Brush   More FDA Info for this Device
510(K) Number	K021998
Device Name	Endoscopic Cytology Brush
Applicant	HORIZONS INTL. CORP. P.O. BOX 7273 PONCE, PR 00732-7273 US Other 510(k) Applications for this Company
Contact	RAFIC SALEH Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	FDX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/19/2002
Decision Date	07/12/2002
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review