FDA 510(k) Application Details - K192465

Device Classification Name	Component, Traction, Invasive   More FDA Info for this Device
510(K) Number	K192465
Device Name	Component, Traction, Invasive
Applicant	Virak Orthopedics, LLC 620 Essex St Harrison, NJ 07029 US Other 510(k) Applications for this Company
Contact	Virak Tan Other 510(k) Applications for this Contact
Regulation Number	888.3040   More FDA Info for this Regulation Number
Classification Product Code	JEC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/09/2019
Decision Date	10/10/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review