FDA 510(k) Application Details - K151357

Device Classification Name	Accessory, Assisted Reproduction   More FDA Info for this Device
510(K) Number	K151357
Device Name	Accessory, Assisted Reproduction
Applicant	AT MEDICAL UAB DRAUGYSTES G.19 KAUNAS 51230 LT Other 510(k) Applications for this Company
Contact	THOMAS PEDERSEN Other 510(k) Applications for this Contact
Regulation Number	884.6120   More FDA Info for this Regulation Number
Classification Product Code	MQG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/20/2015
Decision Date	04/22/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review