FDA 510(k) Application Details - K983015

Device Classification Name	Prosthesis, Penis, Rigid Rod   More FDA Info for this Device
510(K) Number	K983015
Device Name	Prosthesis, Penis, Rigid Rod
Applicant	SPECIALTY SURGICAL PRODUCTS, INC. 302 NORTH FIRST ST. HAMILTON, MT 59840 US Other 510(k) Applications for this Company
Contact	T.JAN VARNER Other 510(k) Applications for this Contact
Regulation Number	876.3630   More FDA Info for this Regulation Number
Classification Product Code	FTQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/28/1998
Decision Date	02/05/1999
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