Device Classification Name |
Bur, Ear, Nose And Throat
More FDA Info for this Device |
510(K) Number |
K041985 |
Device Name |
Bur, Ear, Nose And Throat |
Applicant |
MEDTRONIC XOMED, INC.
6743 SOUTHPOINT DR. NORTH
JACKSONVILLE, FL 32216 US
Other 510(k) Applications for this Company
|
Contact |
MARTIN D SARGENT
Other 510(k) Applications for this Contact |
Regulation Number |
874.4140
More FDA Info for this Regulation Number |
Classification Product Code |
EQJ
Other 510(k) Applications for this Device
More FDA Info for this Product Code |
Date Received |
07/23/2004 |
Decision Date |
08/12/2004 |
Decision |
SESE - SUBST EQUIV |
Classification Advisory Committee |
EN - Ear, Nose, & Throat |
Review Advisory Committee |
EN - Ear, Nose, & Throat |
Statement / Summary / Purged Status |
Summary |
Type |
Traditional |
Reviewed By Third Party |
Y |
Expedited Review |
|