FDA 510(k) Application Details - K013401

Device Classification Name	Accessory, Assisted Reproduction   More FDA Info for this Device
510(K) Number	K013401
Device Name	Accessory, Assisted Reproduction
Applicant	K-SYSTEMS, KIVEX BIOTEC LTD. KLINTEHOJ VAENGE 21 BIRKEROD DA-3460 DK Other 510(k) Applications for this Company
Contact	JACOB MOLLENBACH 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	10/15/2001
Decision Date	12/14/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review