FDA 510(k) Application Details - K983438

Device Classification Name	Device, External Penile Rigidity   More FDA Info for this Device
510(K) Number	K983438
Device Name	Device, External Penile Rigidity
Applicant	DOREA, INC. 19 4TH AVENUE, S.E. CAIRO, GA 31728 US Other 510(k) Applications for this Company
Contact	RICHARD V MOSES,JR. 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	09/29/1998
Decision Date	02/08/1999
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