FDA 510(k) Application Details - K122820

Device Classification Name Cannula, Manipulator/Injector, Uterine

  More FDA Info for this Device
510(K) Number K122820
Device Name Cannula, Manipulator/Injector, Uterine
Applicant ENDOCONTROL
5 avenue du Grand Sablon
La Tronche 38700 FR
Other 510(k) Applications for this Company
Contact HUGUEL CARINE
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 09/14/2012
Decision Date 06/18/2013
Decision SESE - SUBST EQUIV
Classification Advisory Committee OB - Obstetrics/Gynecology
Review Advisory Committee OB - Obstetrics/Gynecology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact