| Device Classification Name |
Catheters, Suction, Tracheobronchial
|
| 510(k) Number |
K870962 |
| Device Name |
GESCO ASPIRATOR |
| Applicant |
| Gesco Intl., Inc. |
| P.O. Box 690188 |
|
San Antonio,
TX
78269
|
|
| Applicant Contact |
GEORGE E SINKO |
| Correspondent |
| Gesco Intl., Inc. |
| P.O. Box 690188 |
|
San Antonio,
TX
78269
|
|
| Correspondent Contact |
GEORGE E SINKO |
| Regulation Number | 868.6810 |
| Classification Product Code |
|
| Date Received | 03/10/1987 |
| Decision Date | 05/22/1987 |
| 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
|
|
|