FDA 510(k) Application Details - K163308

Device Classification Name	Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment   More FDA Info for this Device
510(K) Number	K163308
Device Name	Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment
Applicant	JEIL MEDICAL CORPORATION SEOUL 152-728 KR Other 510(k) Applications for this Company
Contact	JAEHAN PARK Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	KIJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/23/2016
Decision Date	12/27/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review