FDA 510(k) Application Details - K062953

Device Classification Name	Needle, Fistula   More FDA Info for this Device
510(K) Number	K062953
Device Name	Needle, Fistula
Applicant	MEDISYSTEMS CORP. 701 PIKE STREET, SUITE 1600 SEATTLE, WA 98101-3016 US Other 510(k) Applications for this Company
Contact	FREDRIC SWINDLER Other 510(k) Applications for this Contact
Regulation Number	876.5540   More FDA Info for this Regulation Number
Classification Product Code	FIE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/29/2006
Decision Date	02/12/2007
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