| Device Classification Name |
Bottle, Collection, Vacuum
|
| 510(k) Number |
K811955 |
| Device Name |
CALIBRATED BREATHING SYSTEM COLLECTION |
| Applicant |
| Anchor Brush Co., Inc. |
| 803 N. Front St. Suite 3 |
|
Mchenry,
IL
60050
|
|
| Correspondent |
| Anchor Brush Co., Inc. |
| 803 N. Front St. Suite 3 |
|
Mchenry,
IL
60050
|
|
| Regulation Number | 880.6740 |
| Classification Product Code |
|
| Date Received | 07/01/1981 |
| Decision Date | 08/04/1981 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
General Hospital
|
| 510k Review Panel |
General Hospital
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|