FDA 510(k) Application Details - K212659

Device Classification Name	More FDA Info for this Device
510(K) Number	K212659
Device Name	More-Cell-System
Applicant	Agency for Medical Innovations GmbH Im Letten 1 Feldkirch 6800 AT Other 510(k) Applications for this Company
Contact	Martin Hohlrieder Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PMU Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/23/2021
Decision Date	11/10/2021
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