| 510(k) Number |
K862851 |
| Device Name |
ALMORE FACE MASK |
| Applicant |
| Almore Intl., Inc. |
| Post Office Box 25214 |
|
Portland,
OR
97225
|
|
| Applicant Contact |
L. A MORIN |
| Correspondent |
| Almore Intl., Inc. |
| Post Office Box 25214 |
|
Portland,
OR
97225
|
|
| Correspondent Contact |
L. A MORIN |
| Date Received | 07/29/1986 |
| Decision Date | 08/12/1986 |
| Decision |
Substantially Equivalent
(SESE) |
| 510k Review Panel |
General & Plastic Surgery
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|