FDA 510(k) Application Details - K163610

Device Classification Name	Instrument, Surgical, Sonic And Accessory/Attachment   More FDA Info for this Device
510(K) Number	K163610
Device Name	Instrument, Surgical, Sonic And Accessory/Attachment
Applicant	SATALEC-ACTEON GROUP 17 AVENUE GUSTAVE EIFFEL MERIGNAC 33708 FR Other 510(k) Applications for this Company
Contact	PHILIPPE GIRARD Other 510(k) Applications for this Contact
Regulation Number	888.4580   More FDA Info for this Regulation Number
Classification Product Code	JDX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/22/2016
Decision Date	05/19/2017
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