FDA 510(k) Application Details - K110304

Device Classification Name	Powered Laser Surgical Instrument   More FDA Info for this Device
510(K) Number	K110304
Device Name	Powered Laser Surgical Instrument
Applicant	SANDSTONE MEDICAL TECHNOLOGIES LLC 105 CITATION COURT BIRMINGHAM, 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	02/02/2011
Decision Date	04/08/2011
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