FDA 510(k) Application Details - K080697

Device Classification Name	Powered Laser Surgical Instrument   More FDA Info for this Device
510(K) Number	K080697
Device Name	Powered Laser Surgical Instrument
Applicant	GLOBAL USA DISTRIBUTION, LLC. 9220 JAMES AVENUE SOUTH MINNEAPOLIS, MN 55431 US Other 510(k) Applications for this Company
Contact	RONALD BERGLUND Other 510(k) Applications for this Contact
Regulation Number	878.4810   More FDA Info for this Regulation Number
Classification Product Code	GEX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/12/2008
Decision Date	04/07/2008
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	Y
Expedited Review