FDA 510(k) Application Details - K162717

Device Classification Name	Prosthesis, Esophageal   More FDA Info for this Device
510(K) Number	K162717
Device Name	Prosthesis, Esophageal
Applicant	Cook Ireland Ltd. O'Halloran Road, National Technology Park Limerick IE Other 510(k) Applications for this Company
Contact	Jane Kennedy Other 510(k) Applications for this Contact
Regulation Number	878.3610   More FDA Info for this Regulation Number
Classification Product Code	ESW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/29/2016
Decision Date	12/21/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review