FDA 510(k) Application Details - K973120

Device Classification Name	Catheter, Urethral   More FDA Info for this Device
510(K) Number	K973120
Device Name	Catheter, Urethral
Applicant	MEDICAL TECHNOLOGIES OF GEORGIA 5335-A DIVIDEND DR. DECATUR, GA 30035 US Other 510(k) Applications for this Company
Contact	RICHARD STARKE 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	08/20/1997
Decision Date	02/25/1998
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