FDA 510(k) Application Details - K012068

Device Classification Name	Needle, Assisted Reproduction   More FDA Info for this Device
510(K) Number	K012068
Device Name	Needle, Assisted Reproduction
Applicant	SIMS PORTEX LTD. HYTHE HYTHE, KENT CT 21 6JL GB Other 510(k) Applications for this Company
Contact	CLAIRE MULLINS 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	07/02/2001
Decision Date	08/03/2001
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