Device Classification Name |
tube, tracheal (w/wo connector)
|
510(k) Number |
K922880 |
Device Name |
XOMED TREACE JET VENTILATION TUBE |
Applicant |
XOMED-TREACE, INC. |
6743 SOUTHPOINT DRIVE NORTH |
JACKSONVILLE,
FL
32216 -0980
|
|
Applicant Contact |
TERRY C MCMAHON |
Correspondent |
XOMED-TREACE, INC. |
6743 SOUTHPOINT DRIVE NORTH |
JACKSONVILLE,
FL
32216 -0980
|
|
Correspondent Contact |
TERRY C MCMAHON |
Regulation Number | 868.5730
|
Classification Product Code |
|
Date Received | 06/15/1992 |
Decision Date | 04/15/1993 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|