FDA 510(k) Application Details - K971303

Device Classification Name	Cup, Menstrual   More FDA Info for this Device
510(K) Number	K971303
Device Name	Cup, Menstrual
Applicant	ULTRAFEM, INC. 1050 CONNECTICUT AVE., N.W. WASHINGTON, DC 20036-5339 US Other 510(k) Applications for this Company
Contact	PETER S REICHERTZ Other 510(k) Applications for this Contact
Regulation Number	884.5400   More FDA Info for this Regulation Number
Classification Product Code	HHE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/08/1997
Decision Date	06/06/1997
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