FDA 510(k) Application Details - K981357

Device Classification Name	Device, External Penile Rigidity   More FDA Info for this Device
510(K) Number	K981357
Device Name	Device, External Penile Rigidity
Applicant	ERCONS, INC. 66 OVERLOOK TERRACE, SUITE 2E NEW YORK, NY 10040 US Other 510(k) Applications for this Company
Contact	YAKOV ALTSHULER 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	04/14/1998
Decision Date	11/24/1998
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