FDA 510(k) Application Details - K133990

Device Classification Name	Perineometer   More FDA Info for this Device
510(K) Number	K133990
Device Name	Perineometer
Applicant	REMENDIUM LABS, LLC 340 EAST PARKER ROAD BATON ROUGE, LA 70803 US Other 510(k) Applications for this Company
Contact	YOLANDA LORIE Other 510(k) Applications for this Contact
Regulation Number	884.1425   More FDA Info for this Regulation Number
Classification Product Code	HIR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/27/2013
Decision Date	10/09/2014
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review