Device Classification Name |
Light, Ultraviolet, Dermatological
|
510(k) Number |
K863555 |
Device Name |
BREMI BEAUTY BRONZE |
Applicant |
HANDELSONDERNEMING BREMI B.V. |
POSTBUS 47 |
5527 ZG HAPERT |
HOLLAND,
NL
|
|
Applicant Contact |
BREKELMANS |
Correspondent |
HANDELSONDERNEMING BREMI B.V. |
POSTBUS 47 |
5527 ZG HAPERT |
HOLLAND,
NL
|
|
Correspondent Contact |
BREKELMANS |
Regulation Number | 878.4630
|
Classification Product Code |
|
Date Received | 09/12/1986 |
Decision Date | 10/02/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|