FDA 510(k) Application Details - K011435

Device Classification Name	Stimulator, Electrical, Non-Implantable, For Incontinence   More FDA Info for this Device
510(K) Number	K011435
Device Name	Stimulator, Electrical, Non-Implantable, For Incontinence
Applicant	HMT, INC. 3/4 FL. HAK BLDG. 249-13 YANGJAE-DONG, SEOCHO-GU SEOUL 137-130 KR Other 510(k) Applications for this Company
Contact	SEUNG K MO Other 510(k) Applications for this Contact
Regulation Number	876.5320   More FDA Info for this Regulation Number
Classification Product Code	KPI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/10/2001
Decision Date	06/22/2001
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	Y
Expedited Review