FDA 510(k) Application Details - K082803

Device Classification Name	Dislodger, Stone, Basket, Ureteral, Metal   More FDA Info for this Device
510(K) Number	K082803
Device Name	Dislodger, Stone, Basket, Ureteral, Metal
Applicant	PERCUTANEOUS SYSTEMS, INC. 3260 HILLVIEW AVE. PALO ALTO, CA 94304 US Other 510(k) Applications for this Company
Contact	THOMAS LAWSON Other 510(k) Applications for this Contact
Regulation Number	876.4680   More FDA Info for this Regulation Number
Classification Product Code	FFL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/24/2008
Decision Date	11/13/2008
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