FDA 510(k) Application Details - K061489

Device Classification Name	Powered Laser Surgical Instrument   More FDA Info for this Device
510(K) Number	K061489
Device Name	Powered Laser Surgical Instrument
Applicant	MEDICALCV, INC. 9725 SOUTH ROBERT TRAIL INVER GROVE HEIGHTS, MN 55077 US Other 510(k) Applications for this Company
Contact	DENNY STEGER 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	05/31/2006
Decision Date	03/16/2007
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review