| 510(k) Number |
K813220 |
| Device Name |
REGU-VAC OXYGENATING SUCTION CATHETER |
| Applicant |
| Bd Becton Dickinson Vacutainer Systems Preanalytic |
| 1875 Eye St. NW Suite 625 |
|
Washington,
DC
20006
|
|
| Correspondent |
| Bd Becton Dickinson Vacutainer Systems Preanalytic |
| 1875 Eye St. NW Suite 625 |
|
Washington,
DC
20006
|
|
| Date Received | 11/09/1981 |
| Decision Date | 01/22/1982 |
| Decision |
Substantially Equivalent
(SESE) |
| 510k Review Panel |
Cardiovascular
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|