FDA 510(k) Application Details - K191264

Device Classification Name	Intrauterine Tamponade Balloon   More FDA Info for this Device
510(K) Number	K191264
Device Name	Intrauterine Tamponade Balloon
Applicant	Ujenzi Charitable Trust 22 Welgate Road Medford, MA 02155 US Other 510(k) Applications for this Company
Contact	Thomas Burke Other 510(k) Applications for this Contact
Regulation Number	884.4530   More FDA Info for this Regulation Number
Classification Product Code	OQY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/10/2019
Decision Date	10/30/2019
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