FDA 510(k) Application Details - K140761

Device Classification Name	Insufflator, Carbon-Dioxide, Uterotubal (And Accessories)   More FDA Info for this Device
510(K) Number	K140761
Device Name	Insufflator, Carbon-Dioxide, Uterotubal (And Accessories)
Applicant	CAREFUSION 2200 INC. 72 N. FAIRWAY DRIVE VERNON HILLS, IL 60061 US Other 510(k) Applications for this Company
Contact	JANE WEBER Other 510(k) Applications for this Contact
Regulation Number	884.1300   More FDA Info for this Regulation Number
Classification Product Code	HES Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/26/2014
Decision Date	04/21/2014
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