FDA 510(k) Application Details - K200640

Device Classification Name	Filler, Bone Void, Calcium Compound   More FDA Info for this Device
510(K) Number	K200640
Device Name	Filler, Bone Void, Calcium Compound
Applicant	Baxter Healthcare Corporation 25212 W. Illinois Route 120 Round Lake, IL 60073 US Other 510(k) Applications for this Company
Contact	Phillip Romei Other 510(k) Applications for this Contact
Regulation Number	888.3045   More FDA Info for this Regulation Number
Classification Product Code	MQV Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/11/2020
Decision Date	05/08/2020
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