FDA 510(k) Application Details - K060764

Device Classification Name	System, Assisted Reproduction Laser   More FDA Info for this Device
510(K) Number	K060764
Device Name	System, Assisted Reproduction Laser
Applicant	RESEARCH INSTRUMENTS LTD. 3722 AVE. SAUSALITO IRVINE, CA 92606 US Other 510(k) Applications for this Company
Contact	GRACE HOLLAND Other 510(k) Applications for this Contact
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	03/21/2006
Decision Date	03/12/2007
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review