FDA 510(k) Application Details - K133707

Device Classification Name	Media, Reproductive   More FDA Info for this Device
510(K) Number	K133707
Device Name	Media, Reproductive
Applicant	ORIGIO A/S Knardrupvej 2 Maaloev 2760 DK Other 510(k) Applications for this Company
Contact	TOVE KJAER Other 510(k) Applications for this Contact
Regulation Number	884.6180   More FDA Info for this Regulation Number
Classification Product Code	MQL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/04/2013
Decision Date	04/16/2014
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