| Device Classification Name |
Stylet, Tracheal Tube
|
| 510(k) Number |
K952266 |
| Device Name |
SCHROEDER ORAL/NASAL DIRECTIONAL STYLETTE |
| Applicant |
| Stebar Instrument Corp. |
| 3066 Three Mile Rd., NW |
|
Grand Rapids,
MI
49504
|
|
| Applicant Contact |
STEVEN M DAUGHERTY |
| Correspondent |
| Stebar Instrument Corp. |
| 3066 Three Mile Rd., NW |
|
Grand Rapids,
MI
49504
|
|
| Correspondent Contact |
STEVEN M DAUGHERTY |
| Regulation Number | 868.5790 |
| Classification Product Code |
|
| Date Received | 05/15/1995 |
| Decision Date | 06/12/1995 |
| 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
|
|
|