Device Classification Name |
Tube, Tympanostomy
|
510(k) Number |
K941407 |
Device Name |
TYMPANOSTOMY (VENTILATION) TUBE |
Applicant |
XOMED-TREACE, INC. |
6743 SOUTHPOINT DRIVE NORTH |
JACKSONVILLE,
FL
32216 -0980
|
|
Applicant Contact |
ARTHUR A GERTZMAN |
Correspondent |
XOMED-TREACE, INC. |
6743 SOUTHPOINT DRIVE NORTH |
JACKSONVILLE,
FL
32216 -0980
|
|
Correspondent Contact |
ARTHUR A GERTZMAN |
Regulation Number | 874.3880
|
Classification Product Code |
|
Date Received | 03/23/1994 |
Decision Date | 03/14/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ear Nose & Throat
|
510k Review Panel |
Ear Nose & Throat
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|