FDA 510(k) Application Details - K971443

Device Classification Name	Device, External Penile Rigidity   More FDA Info for this Device
510(K) Number	K971443
Device Name	Device, External Penile Rigidity
Applicant	OWEN MUMFORD USA, INC. 849 PICKENS INDUSTRIAL DR. SUITE 14 MARIETTA, GA 30062 US Other 510(k) Applications for this Company
Contact	ROBERT E SHAW 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	04/21/1997
Decision Date	09/26/1997
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