FDA 510(k) Application Details - K151095

Device Classification Name	Clamp, Circumcision   More FDA Info for this Device
510(K) Number	K151095
Device Name	Clamp, Circumcision
Applicant	Novadien Healthcare PO Box 7070 Mount Lewis NSW 2190 AU Other 510(k) Applications for this Company
Contact	Milad Melhem Other 510(k) Applications for this Contact
Regulation Number	884.4530   More FDA Info for this Regulation Number
Classification Product Code	HFX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/23/2015
Decision Date	09/18/2015
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