FDA 510(k) Application Details - K193052

Device Classification Name	Wax,Bone   More FDA Info for this Device
510(K) Number	K193052
Device Name	Wax,Bone
Applicant	Orthocon, Inc. 1 Bridge Street, Suite 121 Irvington, NY 10533 US Other 510(k) Applications for this Company
Contact	Howard Schrayer 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	11/01/2019
Decision Date	03/27/2020
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