FDA 510(k) Application Details - K101563

Device Classification Name	Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment   More FDA Info for this Device
510(K) Number	K101563
Device Name	Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment
Applicant	JEIL MEDICAL CORPORATION 1006 DIGITAL 2CHA VALLEY BYUCKSAN, GASAN- DONG, GEUMCHE SEOUL KR Other 510(k) Applications for this Company
Contact	KIM SEONG NAM 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	06/04/2010
Decision Date	12/17/2010
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review