FDA 510(k) Application Details - K091467

Device Classification Name	Powered Light Based Non-Laser Surgical Instrument   More FDA Info for this Device
510(K) Number	K091467
Device Name	Powered Light Based Non-Laser Surgical Instrument
Applicant	SILVER BAY, LLC 333 MILFORD ROAD DEERFIELD, IL 60015 US Other 510(k) Applications for this Company
Contact	DANIEL KAMM, P.E. Other 510(k) Applications for this Contact
Regulation Number	878.4810   More FDA Info for this Regulation Number
Classification Product Code	ONE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/18/2009
Decision Date	09/17/2010
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review