FDA 510(k) Application Details - K201213

Device Classification Name	Labware, Assisted Reproduction   More FDA Info for this Device
510(K) Number	K201213
Device Name	Labware, Assisted Reproduction
Applicant	HertART Aps Gustaf Werners gata 2 Vastra Frolunda SE-421 32 SE Other 510(k) Applications for this Company
Contact	Per Svensson Other 510(k) Applications for this Contact
Regulation Number	884.6160   More FDA Info for this Regulation Number
Classification Product Code	MQK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/05/2020
Decision Date	12/16/2020
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