FDA 510(k) Application Details - K183619

Device Classification Name	Prosthesis, Penile   More FDA Info for this Device
510(K) Number	K183619
Device Name	Prosthesis, Penile
Applicant	Boston Scientific Corporation 10700 Bren Road West Minnetonka, MN 55343 US Other 510(k) Applications for this Company
Contact	Laura Kelly Other 510(k) Applications for this Contact
Regulation Number	876.3630   More FDA Info for this Regulation Number
Classification Product Code	FAE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/26/2018
Decision Date	04/16/2019
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