FDA 510(k) Application Details - K081219

Device Classification Name	Powered Laser Surgical Instrument   More FDA Info for this Device
510(K) Number	K081219
Device Name	Powered Laser Surgical Instrument
Applicant	SANDSTONE MEDICAL TECHNOLOGIES, LLC 102 OXMOOR RD. SUITE 13 HOMEWOOD, AL 35209 US Other 510(k) Applications for this Company
Contact	MARK ROHRER 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	04/30/2008
Decision Date	06/30/2008
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	N
Expedited Review