FDA 510(k) Application Details - K180068

Device Classification Name	More FDA Info for this Device
510(K) Number	K180068
Device Name	ORISE Gel
Applicant	Boston Scientific 100 Boston Scientific Way Marlborough, MA 01752 US Other 510(k) Applications for this Company
Contact	Thomas Hirte Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PLL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/09/2018
Decision Date	09/28/2018
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