FDA 510(k) Application Details - K143191

Device Classification Name	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment   More FDA Info for this Device
510(K) Number	K143191
Device Name	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
Applicant	McGinley Innovations 2435 King Blvd, Suite 230 Casper, WY 82604 US Other 510(k) Applications for this Company
Contact	Joseph McGinley Other 510(k) Applications for this Contact
Regulation Number	878.4820   More FDA Info for this Regulation Number
Classification Product Code	HWE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/06/2014
Decision Date	02/20/2015
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