FDA 510(k) Application Details - K011552

Device Classification Name	Catheter, Urethral   More FDA Info for this Device
510(K) Number	K011552
Device Name	Catheter, Urethral
Applicant	APOGEE MEDICAL, INC. 90 WEATHERS ST. YOUNGSVILLE, NC 27549 US Other 510(k) Applications for this Company
Contact	BRENT D ROBLING Other 510(k) Applications for this Contact
Regulation Number	876.5130   More FDA Info for this Regulation Number
Classification Product Code	GBM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/18/2001
Decision Date	07/18/2001
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