FDA 510(k) Application Details - K083208

Device Classification Name	System, Assisted Reproduction Laser   More FDA Info for this Device
510(K) Number	K083208
Device Name	System, Assisted Reproduction Laser
Applicant	RESEARCH INSTRUMENTS LTD. BICKLAND INDUSTRIAL PARK FALMOUTH, CORNWALL TR11 4TA GB Other 510(k) Applications for this Company
Regulation Number	884.6200   More FDA Info for this Regulation Number
Classification Product Code	MRX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/31/2008
Decision Date	08/25/2009
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review