| Device Classification Name |
Device, Fixation, Tracheal Tube
|
| 510(k) Number |
K933420 |
| Device Name |
BREATHING TUBE SUPPORT |
| Applicant |
| Blake Medical, Inc. |
| P.O. Box 1255 |
|
Tifton,
GA
31793
|
|
| Applicant Contact |
MARK B LOTT |
| Correspondent |
| Blake Medical, Inc. |
| P.O. Box 1255 |
|
Tifton,
GA
31793
|
|
| Correspondent Contact |
MARK B LOTT |
| Regulation Number | 868.5770 |
| Classification Product Code |
|
| Date Received | 07/13/1993 |
| Decision Date | 10/13/1993 |
| 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
|
|
|