FDA 510(k) Application Details - K172128

Device Classification Name	More FDA Info for this Device
510(K) Number	K172128
Device Name	EsoFLIP« ES-310 Balloon Catheter
Applicant	Crospon Ltd. Galway Business Park Dangan Galway IE Other 510(k) Applications for this Company
Contact	John OÆDea Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PIE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/14/2017
Decision Date	11/22/2017
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