FDA 510(k) Application Details - K992137

Device Classification Name	Catheter, Urethral   More FDA Info for this Device
510(K) Number	K992137
Device Name	Catheter, Urethral
Applicant	APOGEE, INC. 7517-101 PRECISION DR. RALEIGH, NC 27613 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	06/24/1999
Decision Date	09/03/1999
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