FDA 510(k) Application Details - K043480

Device Classification Name	Device, Engorgement, Clitoral   More FDA Info for this Device
510(K) Number	K043480
Device Name	Device, Engorgement, Clitoral
Applicant	GYNAVATIONS, INC. 665 SALEM STREET MALDEN, MA 02148 US Other 510(k) Applications for this Company
Contact	DAVID GLOTH Other 510(k) Applications for this Contact
Regulation Number	884.5970   More FDA Info for this Regulation Number
Classification Product Code	NBV Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/16/2004
Decision Date	06/08/2005
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