FDA 510(k) Application Details - K231203

Device Classification Name	More FDA Info for this Device
510(K) Number	K231203
Device Name	Mosie Baby Kit
Applicant	Mosie Baby P.O. Box 140753 Austin, TX 78714 US Other 510(k) Applications for this Company
Contact	Maureen Brown Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QYZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/27/2023
Decision Date	11/29/2023
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