FDA 510(k) Application Details - K023465

Device Classification Name	Accessory, Assisted Reproduction   More FDA Info for this Device
510(K) Number	K023465
Device Name	Accessory, Assisted Reproduction
Applicant	KENDRO LABORATORY PRODUCTS, L.P. P.O. BOX 2156 HUNTINGTON, CT 06484 US Other 510(k) Applications for this Company
Contact	JOSEPH M AZARY Other 510(k) Applications for this Contact
Regulation Number	884.6120   More FDA Info for this Regulation Number
Classification Product Code	MQG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/15/2002
Decision Date	03/10/2003
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