Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K133447
Device Classification Name
Agents,Embolic,For Treatment Of Uterine Fibroids
More FDA Info for this Device
510(K) Number
K133447
Device Name
Agents,Embolic,For Treatment Of Uterine Fibroids
Applicant
CELONOVA BIOSCIENCES, INC.
18615 TUSCANY STONE
SUITE 100
SAN ANTONIO, TX 78258 US
Other 510(k) Applications for this Company
Contact
NICOLE BARBER
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
11/12/2013
Decision Date
02/24/2014
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