FDA 510(k) Application Details - K030810

Device Classification Name	Powered Laser Surgical Instrument   More FDA Info for this Device
510(K) Number	K030810
Device Name	Powered Laser Surgical Instrument
Applicant	COOLANALGESIA LTD. WILLIAM GATES BUILDING 15 J.J. THOMSON AVENUE CAMBRIDGE, ENGLAND CB3 0FD GB Other 510(k) Applications for this Company
Contact	PETER WILKINSON 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	03/13/2003
Decision Date	05/05/2004
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	Y
Expedited Review