FDA 510(k) Application Details - K190499

Device Classification Name	Device,Anastomotic,Microvascular   More FDA Info for this Device
510(K) Number	K190499
Device Name	Device,Anastomotic,Microvascular
Applicant	Baxter/ Synovis Micro Companies Alliance Inc. 2875 University Ave. West St. Paul, MN 55114 US Other 510(k) Applications for this Company
Contact	Julie Carlston Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	MVR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/01/2019
Decision Date	09/06/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review