FDA 510(k) Application Details - K991479

Device Classification Name	Monitor, Penile Tumescence   More FDA Info for this Device
510(K) Number	K991479
Device Name	Monitor, Penile Tumescence
Applicant	LABORIE MEDICAL TECH CORP. 310 HURRICANE LN. #2 WILLISTON, VT 05495 US Other 510(k) Applications for this Company
Contact	DALE COLEMAN 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	04/28/1999
Decision Date	07/07/1999
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review