FDA 510(k) Application Details - K954215

Device Classification Name	External Urethral Occluder, Urinary Incontinence-Control, Female   More FDA Info for this Device
510(K) Number	K954215
Device Name	External Urethral Occluder, Urinary Incontinence-Control, Female
Applicant	ADVANCED SURGICAL INTERVENTION, INC. P.O BOX 3134 DANA POINT, CA 92629 US Other 510(k) Applications for this Company
Contact	ROBERT F ROSENBLUTH Other 510(k) Applications for this Contact
Regulation Number	876.5160   More FDA Info for this Regulation Number
Classification Product Code	MNG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/08/1995
Decision Date	05/08/1996
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	Y