FDA 510(k) Application Details - K980627

Device Classification Name	Monitor, Penile Tumescence   More FDA Info for this Device
510(K) Number	K980627
Device Name	Monitor, Penile Tumescence
Applicant	UROMETRICS, INC. 445 ETNA ST., SUITE 56 ST. PAUL, MN 55106 US Other 510(k) Applications for this Company
Contact	PHILIP A MESSINA 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	02/18/1998
Decision Date	04/07/1998
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