FDA 510(k) Application Details - K974645

Device Classification Name	External Urethral Occluder, Urinary Incontinence-Control, Female   More FDA Info for this Device
510(K) Number	K974645
Device Name	External Urethral Occluder, Urinary Incontinence-Control, Female
Applicant	INSIGHT MEDICAL CORP. 580 MAIN ST. BOLTON, MA 01740 US Other 510(k) Applications for this Company
Contact	MICHAEL G VERGANO 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	12/12/1997
Decision Date	02/12/1998
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