FDA 510(k) Application Details - K090429

Device Classification Name	Labware, Assisted Reproduction   More FDA Info for this Device
510(K) Number	K090429
Device Name	Labware, Assisted Reproduction
Applicant	THERMO FISHER SCIENTIFIC (NALGE NUNC INTL) 75 PANORAMA CREEK DRIVE ROCHESTER, NY 14625-2385 US Other 510(k) Applications for this Company
Contact	ROBERT PRESCOTT Other 510(k) Applications for this Contact
Regulation Number	884.6160   More FDA Info for this Regulation Number
Classification Product Code	MQK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/19/2009
Decision Date	09/18/2009
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