| 510(k) Number |
K843543 |
| Device Name |
THE BIBICURE SYS DERMEPIL NATURAL HAIR |
| Applicant |
| Les Entreprises Bibi, Inc. |
| 55 Louvain Auest Suite 418 |
| Quebec |
|
Montreal H2n1a4,
CA
|
|
| Applicant Contact |
PIA DAMTSIS |
| Correspondent |
| Les Entreprises Bibi, Inc. |
| 55 Louvain Auest Suite 418 |
| Quebec |
|
Montreal H2n1a4,
CA
|
|
| Correspondent Contact |
PIA DAMTSIS |
| Date Received | 09/07/1984 |
| Decision Date | 11/07/1984 |
| 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
|
|
|