| 510(k) Number |
K852904 |
| Device Name |
ESTERIPAPEL BAGS |
| Applicant |
| Sophlaril Hispania, S. A. |
| Bartoli |
| Industria, 218, Entlo., 2a |
|
08026 Barcelona, Spain,
ES
|
|
| Correspondent |
| Sophlaril Hispania, S. A. |
| Bartoli |
| Industria, 218, Entlo., 2a |
|
08026 Barcelona, Spain,
ES
|
|
| Date Received | 07/09/1985 |
| Decision Date | 07/26/1985 |
| 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
|
|
|