FDA 510(k) Application Details - K033354

Device Classification Name	Powered Laser Surgical Instrument   More FDA Info for this Device
510(K) Number	K033354
Device Name	Powered Laser Surgical Instrument
Applicant	20/10 PERFECT VISION OPTISCHE GERATE GMBH 21911 ERIE LANE LAKE FOREST, CA 92630 US Other 510(k) Applications for this Company
Contact	CAROL PATTERSON 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	10/20/2003
Decision Date	02/18/2004
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