FDA 510(k) Application Details - K032840

Device Classification Name	Dilator, Urethral   More FDA Info for this Device
510(K) Number	K032840
Device Name	Dilator, Urethral
Applicant	ATRION MEDICAL PRODUCTS, INC. 1426 CURT FRANCIS RD. ARAB, AL 35016 US Other 510(k) Applications for this Company
Contact	DAN CLARK Other 510(k) Applications for this Contact
Regulation Number	876.5520   More FDA Info for this Regulation Number
Classification Product Code	KOE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/11/2003
Decision Date	03/03/2004
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review