FDA 510(k) Application Details - K974057

Device Classification Name	Powered Laser Surgical Instrument   More FDA Info for this Device
510(K) Number	K974057
Device Name	Powered Laser Surgical Instrument
Applicant	DENTEK LASERSYSTEMS PRODUKTIONS GES.M.B.H. 1819 SOUTH MAY STREET, 2F CHICAGO, IL 60608 US Other 510(k) Applications for this Company
Contact	ROBERT W BAUER 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	10/27/1997
Decision Date	04/21/1998
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