FDA 510(k) Application Details - K101900

Device Classification Name	Catheter, Urethral   More FDA Info for this Device
510(K) Number	K101900
Device Name	Catheter, Urethral
Applicant	HAKKI MEDICAL TECHNOLOGIES, INC. 3851 62ND AVE. NORTH SUITE A PINELLAS PARK, FL 33781 US Other 510(k) Applications for this Company
Contact	ANDREW ENDAHL 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	07/07/2010
Decision Date	02/07/2011
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