Device Classification Name |
condom
|
510(k) Number |
K051288 |
Device Name |
VIELLE LUBRICANT |
Applicant |
CST MEDICAL LIMITED |
1676 VILLAGE GREEN |
SUITE A |
crofton,
MD
21114
|
|
Applicant Contact |
christian smith |
Correspondent |
CST MEDICAL LIMITED |
1676 VILLAGE GREEN |
SUITE A |
crofton,
MD
21114
|
|
Correspondent Contact |
christian smith |
Regulation Number | 884.5300
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 05/18/2005 |
Decision Date | 02/03/2006 |
Decision |
substantially equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
summary |
summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|