FDA 510(k) Application Details - K060234

Device Classification Name	Powered Laser Surgical Instrument   More FDA Info for this Device
510(K) Number	K060234
Device Name	Powered Laser Surgical Instrument
Applicant	MCCUE PLC SOLENT INDUSTRIAL ESTATE HEDGE END. SOUTHAMPTON, HAMPSHIRE SO30-2FY GB Other 510(k) Applications for this Company
Contact	STEVEN PEACH 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	01/30/2006
Decision Date	03/15/2006
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