FDA 510(k) Application Details - K142348

Device Classification Name	Wax,Bone   More FDA Info for this Device
510(K) Number	K142348
Device Name	Wax,Bone
Applicant	HEMOSTASIS, LLC 5000 TOWNSHIP PARKWAY ST. PAUL, MN 55110 US Other 510(k) Applications for this Company
Contact	Bernard Horwath Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	MTJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/22/2014
Decision Date	01/23/2015
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review