FDA 510(k) Application Details - K001859

Device Classification Name	Device, External Penile Rigidity   More FDA Info for this Device
510(K) Number	K001859
Device Name	Device, External Penile Rigidity
Applicant	BASIC SOLUTIONS, LLC. 2425 W. OLYMPIC BLVD. WEST TOWER, SUITE 4000 SANTA MONICA, CA 90404 US Other 510(k) Applications for this Company
Contact	JAY H GELLER 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	06/19/2000
Decision Date	01/11/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review