FDA 510(k) Application Details - K972091

Device Classification Name	Dislodger, Stone, Basket, Ureteral, Metal   More FDA Info for this Device
510(K) Number	K972091
Device Name	Dislodger, Stone, Basket, Ureteral, Metal
Applicant	AMERICAN MEDICAL SYSTEMS, INC. 10700 BREN RD., WEST MINNETONKA, MN 55343 US Other 510(k) Applications for this Company
Contact	LISA L PRITCHARD 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	06/04/1997
Decision Date	08/29/1997
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