FDA 510(k) Application Details - K030235

Device Classification Name	Powered Laser Surgical Instrument   More FDA Info for this Device
510(K) Number	K030235
Device Name	Powered Laser Surgical Instrument
Applicant	OPUS MEDICAL, INC. 1684 EAST GUDE DR. SUITE 202 ROCKVILLE, MD 20850 US Other 510(k) Applications for this Company
Contact	RENE VAN DE ZANDE 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	01/23/2003
Decision Date	04/23/2003
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