FDA 510(k) Application Details - K993142

Device Classification Name	Device, External Penile Rigidity   More FDA Info for this Device
510(K) Number	K993142
Device Name	Device, External Penile Rigidity
Applicant	SOMA BLUE, INC. P.O. BOX 1447 1025 BROAD STREET AUGUSTA, GA 30903 US Other 510(k) Applications for this Company
Contact	JOHN M MITCHELL 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	09/21/1999
Decision Date	12/27/1999
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