| 510(k) Number |
K851851 |
| Device Name |
STERILE ENDOTRACHEAL BRUSHES |
| Applicant |
| Biological & Environmental Control Laboratories |
| 615 Front St. |
|
Toledo,
OH
43605
|
|
| Applicant Contact |
NORMAN HUFF |
| Correspondent |
| Biological & Environmental Control Laboratories |
| 615 Front St. |
|
Toledo,
OH
43605
|
|
| Correspondent Contact |
NORMAN HUFF |
| Date Received | 04/26/1985 |
| Decision Date | 06/05/1985 |
| Decision |
Substantially Equivalent
(SESE) |
| 510k Review Panel |
Cardiovascular
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|