| Device Classification Name |
Tube, Tracheal (W/Wo Connector)
|
| 510(k) Number |
K843936 |
| Device Name |
MONTGOMERY SAFE-T-TUBE |
| Applicant |
| Boston Medical Products, Inc. |
| 100 Charles River Plz. |
| 5th Floor |
|
Boston,
MA
02114
|
|
| Applicant Contact |
STUART K MONTGOMERY |
| Correspondent |
| Boston Medical Products, Inc. |
| 100 Charles River Plz. |
| 5th Floor |
|
Boston,
MA
02114
|
|
| Correspondent Contact |
STUART K MONTGOMERY |
| Regulation Number | 868.5730 |
| Classification Product Code |
|
| Date Received | 10/09/1984 |
| Decision Date | 12/14/1984 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Anesthesiology
|
| 510k Review Panel |
Anesthesiology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|