FDA 510(k) Application Details - K974730

Device Classification Name	Monitor, Pressure, Intrauterine   More FDA Info for this Device
510(K) Number	K974730
Device Name	Monitor, Pressure, Intrauterine
Applicant	GRAPHIC CONTROLS CORP. 189 VAN RENSSELAER ST. P.O. BOX 1274 BUFFALO, NY 14240 US Other 510(k) Applications for this Company
Contact	KATHLEEN H SELOVER Other 510(k) Applications for this Contact
Regulation Number	884.2700   More FDA Info for this Regulation Number
Classification Product Code	KXO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/18/1997
Decision Date	07/14/1998
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