FDA 510(k) Application Details - K151567

Device Classification Name	Coagulator, Culdoscopic (And Accessories)   More FDA Info for this Device
510(K) Number	K151567
Device Name	Coagulator, Culdoscopic (And Accessories)
Applicant	ENDOPLUS 750 Tower Road, Suite A Mundelein, IL 60060 US Other 510(k) Applications for this Company
Contact	Matthew Gudeman Other 510(k) Applications for this Contact
Regulation Number	884.4160   More FDA Info for this Regulation Number
Classification Product Code	HFI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/10/2015
Decision Date	12/23/2015
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