FDA 510(k) Application Details - K160278

Device Classification Name	Manipulator, Plunger-Like Joint   More FDA Info for this Device
510(K) Number	K160278
Device Name	Manipulator, Plunger-Like Joint
Applicant	SPINAL ACOUSTICS, LLC 640 FOURTH STREET BEAVER, PA 15009 US Other 510(k) Applications for this Company
Contact	ALBERT A. TORRENCE Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	LXM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/02/2016
Decision Date	11/04/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	PM - Physical Medicine
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review