FDA 510(k) Application Details - K020082

Device Classification Name	Device, External Penile Rigidity   More FDA Info for this Device
510(K) Number	K020082
Device Name	Device, External Penile Rigidity
Applicant	ENDOCARE, INC. 6585 CITY WEST PKWY. EDEN PRAIRIE, MN 55344 US Other 510(k) Applications for this Company
Contact	CHRIS HADLAND Other 510(k) Applications for this Contact
Regulation Number	876.5020   More FDA Info for this Regulation Number
Classification Product Code	LKY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/10/2002
Decision Date	02/05/2002
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review