FDA 510(k) Application Details - K181192

Device Classification Name	Component, Traction, Invasive   More FDA Info for this Device
510(K) Number	K181192
Device Name	Component, Traction, Invasive
Applicant	Hand Biomechanics Lab, Inc. 77 Scripps Drive, Suite 104 Sacramento, CA 95825 US Other 510(k) Applications for this Company
Contact	Dustin Dequine 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	05/04/2018
Decision Date	10/22/2018
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review