FDA 510(k) Application Details - K002805

Device Classification Name	Accessory, Assisted Reproduction   More FDA Info for this Device
510(K) Number	K002805
Device Name	Accessory, Assisted Reproduction
Applicant	KENDRO LABORATORY PRODUCTS, L.P. 55 NORTHERN BLVD.; SUITE 200 GREAT NECK, NY 11021 US Other 510(k) Applications for this Company
Contact	SUSAN D GOLDSTEIN-FALK 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	09/08/2000
Decision Date	11/09/2000
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