FDA 510(k) Application Details - K964279

Device Classification Name	Monitor, Pressure, Intrauterine   More FDA Info for this Device
510(K) Number	K964279
Device Name	Monitor, Pressure, Intrauterine
Applicant	GRAPHIC CONTROLS CORP. 189 VAN RENSSELAER ST. P.O. BOX 1271 BUAFFLO, NY 14240-1271 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	10/28/1996
Decision Date	01/22/1997
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