510(k) K130259

BEARING NSPVA EMBOLIZATION PARTICLES by Merit Medical Systems, Inc. — Product Code NAJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 7, 2013
Date Received
February 1, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Agents, Embolic, For Treatment Of Uterine Fibroids
Device Class
Class II
Regulation Number
870.3300
Review Panel
OB
Submission Type