FDA 510(k) Application Details - K063104

Device Classification Name	Powered Laser Surgical Instrument   More FDA Info for this Device
510(K) Number	K063104
Device Name	Powered Laser Surgical Instrument
Applicant	HOWARD INSTRUMENTS, INC. 4749 APPLETREE LN. TUSCALOOSA, AL 35405-5747 US Other 510(k) Applications for this Company
Contact	JACK HOWARD 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	08/10/2006
Decision Date	05/16/2007
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	N
Expedited Review