FDA 510(k) Application Details - K991020

Device Classification Name	Needle, Assisted Reproduction   More FDA Info for this Device
510(K) Number	K991020
Device Name	Needle, Assisted Reproduction
Applicant	INTL., INC. 170 FORT PATH RD. UNIT 14 MADISON, CT 06443 US Other 510(k) Applications for this Company
Contact	MICHAEL D CECCHI 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	03/29/1999
Decision Date	09/09/1999
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