Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K130259
Device Classification Name
Agents,Embolic,For Treatment Of Uterine Fibroids
More FDA Info for this Device
510(K) Number
K130259
Device Name
Agents,Embolic,For Treatment Of Uterine Fibroids
Applicant
MERIT MEDICAL SYSTEMS, INC.
1050 HINGHAM ST
ROCKLAND, MA 02370 US
Other 510(k) Applications for this Company
Contact
LINDA VARROSO
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
02/01/2013
Decision Date
06/07/2013
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
OB - Obstetrics/Gynecology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact