Device Classification Name |
Replacement, Ossicular Prosthesis, Total
More FDA Info for this Device |
510(K) Number |
K091187 |
Device Name |
Replacement, Ossicular Prosthesis, Total |
Applicant |
Grace Medical, Inc.
8500 WOLF LAKE DR., STE. 110
MEMPHIS, TN 38133 US
Other 510(k) Applications for this Company
|
Contact |
JEFF COBB
Other 510(k) Applications for this Contact |
Regulation Number |
874.3495
More FDA Info for this Regulation Number |
Classification Product Code |
ETA
Other 510(k) Applications for this Device
More FDA Info for this Product Code |
Date Received |
04/23/2009 |
Decision Date |
09/14/2009 |
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 |
N |
Expedited Review |
|