FDA 510(k) Application Details - K100662

Device Classification Name	Cannula, Manipulator/Injector, Uterine   More FDA Info for this Device
510(K) Number	K100662
Device Name	Cannula, Manipulator/Injector, Uterine
Applicant	FEMASYS INC. 5000 RESEARCH COURT STE .100 SUWANEE, GA 30024 US Other 510(k) Applications for this Company
Contact	LISA PEACOCK Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	LKF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/08/2010
Decision Date	04/07/2010
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review