FDA 510(k) Application Details - K973850

Device Classification Name	Recorder, Pressure, Intrauterine   More FDA Info for this Device
510(K) Number	K973850
Device Name	Recorder, Pressure, Intrauterine
Applicant	ALEXANDER MFG. CO. 1511 S GARFIELD PL MASON CITY, IA 50401 US Other 510(k) Applications for this Company
Contact	KEN HEIMENDINGER Other 510(k) Applications for this Contact
Regulation Number	884.2700   More FDA Info for this Regulation Number
Classification Product Code	HFO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/08/1997
Decision Date	11/12/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review