FDA 510(k) Application Details - K191966

Device Classification Name	Prosthesis, Toe, Constrained, Polymer   More FDA Info for this Device
510(K) Number	K191966
Device Name	Prosthesis, Toe, Constrained, Polymer
Applicant	BRM Extremities Via Ciro Menotti 10 Milano, MI 20129 US Other 510(k) Applications for this Company
Contact	Andrea De Maglio Other 510(k) Applications for this Contact
Regulation Number	888.3720   More FDA Info for this Regulation Number
Classification Product Code	KWH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/23/2019
Decision Date	02/13/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review