FDA 510(k) Application Details - K000205

Device Classification Name	Needle, Assisted Reproduction   More FDA Info for this Device
510(K) Number	K000205
Device Name	Needle, Assisted Reproduction
Applicant	ROCKET MEDICAL PLC WARE INDUSTRIAL ESTATE WASHINGTON, TYNE & WEAR NE37 1NE GB Other 510(k) Applications for this Company
Contact	LES TODD 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	01/21/2000
Decision Date	04/19/2000
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