FDA 510(k) Application Details - K181692

Device Classification Name	Marker, Radiographic, Implantable   More FDA Info for this Device
510(K) Number	K181692
Device Name	Marker, Radiographic, Implantable
Applicant	Health Beacons, Inc. 34 Walden St., #753 Concord, MA 01742 US Other 510(k) Applications for this Company
Contact	Nancy Confrey Other 510(k) Applications for this Contact
Regulation Number	878.4300   More FDA Info for this Regulation Number
Classification Product Code	NEU Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/27/2018
Decision Date	09/25/2018
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