FDA 510(k) Application Details - K974563

Device Classification Name	Elevator, Uterine   More FDA Info for this Device
510(K) Number	K974563
Device Name	Elevator, Uterine
Applicant	CLINICAL INNOVATIONS, INC. 6477 SOUTH COTTONWOOD ST. MURRAY, UT 84107 US Other 510(k) Applications for this Company
Contact	WM. DEAN WALLACE Other 510(k) Applications for this Contact
Regulation Number	884.4530   More FDA Info for this Regulation Number
Classification Product Code	HDP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/05/1997
Decision Date	03/02/1998
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