FDA 510(k) Application Details - K983642

Device Classification Name	Accessory, Assisted Reproduction   More FDA Info for this Device
510(K) Number	K983642
Device Name	Accessory, Assisted Reproduction
Applicant	COOK OB/GYN 1100 WEST MORGAN ST. P.O. BOX 271 SPENCER, IN 47460 US Other 510(k) Applications for this Company
Contact	BRENDA DAVIS 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	10/16/1998
Decision Date	02/01/1999
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