FDA 510(k) Application Details - K233813

Device Classification Name	Agents,Embolic,For Treatment Of Uterine Fibroids   More FDA Info for this Device
510(K) Number	K233813
Device Name	Agents,Embolic,For Treatment Of Uterine Fibroids
Applicant	Merit Medical Systems, Inc. 1600 West Merit Parkway South Jordan, UT 84095 US Other 510(k) Applications for this Company
Contact	Mark Mullaney Other 510(k) Applications for this Contact
Regulation Number	870.3300   More FDA Info for this Regulation Number
Classification Product Code	NAJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/30/2023
Decision Date	12/21/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review