FDA 510(k) Application Details - K023930

Device Classification Name	Needle, Assisted Reproduction   More FDA Info for this Device
510(K) Number	K023930
Device Name	Needle, Assisted Reproduction
Applicant	COOPERSURGICAL, INC. 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	884.6100   More FDA Info for this Regulation Number
Classification Product Code	MQE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/25/2002
Decision Date	01/22/2003
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