FDA 510(k) Application Details - K000730

Device Classification Name	Device, External Penile Rigidity   More FDA Info for this Device
510(K) Number	K000730
Device Name	Device, External Penile Rigidity
Applicant	IMPOAID, INC. P.O. BOX 560 STILLWATER, MN 55082 US Other 510(k) Applications for this Company
Contact	ELAIN DUNCAN 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	03/06/2000
Decision Date	10/19/2000
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	N
Expedited Review