Device Classification Name |
condom
|
510(k) Number |
K083817 |
Device Name |
M. DIOR BRAND |
Applicant |
SUZHOU COLOUR-WAY ENTERPRISE DEVELOPMENT CO., LTD. |
RM. 1606, BLDG. 1, JIANXIANG - |
YUAN NO.209 BEI SI HUAN ZHONG |
haidian district, beijing,
CN
100083
|
|
Applicant Contact |
chu xiaoan |
Correspondent |
SUZHOU COLOUR-WAY ENTERPRISE DEVELOPMENT CO., LTD. |
RM. 1606, BLDG. 1, JIANXIANG - |
YUAN NO.209 BEI SI HUAN ZHONG |
haidian district, beijing,
CN
100083
|
|
Correspondent Contact |
chu xiaoan |
Regulation Number | 884.5300
|
Classification Product Code |
|
Date Received | 12/22/2008 |
Decision Date | 09/16/2009 |
Decision |
substantially equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
summary |
summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|