FDA 510(k) Application Details - K052929

Device Classification Name	Monitor, Penile Tumescence   More FDA Info for this Device
510(K) Number	K052929
Device Name	Monitor, Penile Tumescence
Applicant	LIMESTONE TECHNOLOGIES INC. 4 INNOVATION DRIVE DUNDAS L9H 7P3 CA Other 510(k) Applications for this Company
Contact	NANCY RUTH Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	LIL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/19/2005
Decision Date	04/26/2006
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review