FDA 510(k) Application Details - K151802

Device Classification Name	More FDA Info for this Device
510(K) Number	K151802
Device Name	Resolution Clip
Applicant	BOSTON SCIENTIFIC CORPORATION 100 BOSTON SCIENTIFIC WAY MARLBOROUGH, MA 01752 US Other 510(k) Applications for this Company
Contact	ELENA NIEVES Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PKL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/02/2015
Decision Date	08/06/2015
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