FDA 510(k) Application Details - K982565

Device Classification Name	Monitor, Pressure, Intrauterine   More FDA Info for this Device
510(K) Number	K982565
Device Name	Monitor, Pressure, Intrauterine
Applicant	CARL SCHUH 10915 LURLINE AVE. CHATSOWRTH, CA 91311-1638 US Other 510(k) Applications for this Company
Contact	CARL SCHUH 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	07/23/1998
Decision Date	09/22/1998
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