FDA 510(k) Application Details - K181673

Device Classification Name	Prosthesis, Penile   More FDA Info for this Device
510(K) Number	K181673
Device Name	Prosthesis, Penile
Applicant	Rigicon Inc. 150 Motor Pkwy S401 Hauppauge, NY 11788 US Other 510(k) Applications for this Company
Contact	Ahmet Melih Luleci 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	06/25/2018
Decision Date	04/15/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review