FDA 510(k) Application Details - DEN040009

Device Classification Name	System, Assisted Reproduction Laser   More FDA Info for this Device
510(K) Number	DEN040009
Device Name	System, Assisted Reproduction Laser
Applicant	HAMILTON THORNE BIOSCIENCES 100 CUMMINGS CENTER, SUITE 465E BEVERLY, MA 01915 US Other 510(k) Applications for this Company
Contact	DIARMAID DOUGLAS-HAMILTON 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	08/25/2004
Decision Date	11/04/2004
Decision	DENG -
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status
Type	Post-NSE
Reviewed By Third Party	N
Expedited Review