| Device Classification Name |
Tube, Tracheal (W/Wo Connector)
|
| 510(k) Number |
K030792 |
| Device Name |
BARD ENDOTRACHEAL TUBE, CUFFED |
| Applicant |
| C.R. Bard, Inc. |
| 8195 Industrial Blvd. |
|
Covington,
GA
30014
|
|
| Applicant Contact |
FRANCES E HARRISON |
| Correspondent |
| C.R. Bard, Inc. |
| 8195 Industrial Blvd. |
|
Covington,
GA
30014
|
|
| Correspondent Contact |
FRANCES E HARRISON |
| Regulation Number | 868.5730 |
| Classification Product Code |
|
| Date Received | 03/12/2003 |
| Decision Date | 11/14/2003 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Anesthesiology
|
| 510k Review Panel |
Anesthesiology
|
| Summary |
Summary
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|