FDA 510(k) Application Details - K171271

Device Classification Name	More FDA Info for this Device
510(K) Number	K171271
Device Name	Polyform Synthetic Mesh
Applicant	Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752 US Other 510(k) Applications for this Company
Contact	Michelle Berry Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OTO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/01/2017
Decision Date	12/15/2017
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review