FDA 510(k) Application Details - K000628

Device Classification Name	Needle, Assisted Reproduction   More FDA Info for this Device
510(K) Number	K000628
Device Name	Needle, Assisted Reproduction
Applicant	SIMS PORTEX LTD. HYTHE KENT CT21 6JL GB Other 510(k) Applications for this Company
Contact	GILES BISHOP 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	02/24/2000
Decision Date	03/13/2000
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