Device Classification Name |
Condom
|
510(k) Number |
K982924 |
Device Name |
DUREX SENSIDOM LATEX CONDOM |
Applicant |
LONDON INTL. LLC. |
2926 COLUMBIA HWY. |
P.O. BOX 8308 |
DOTHAN,
AL
36304
|
|
Applicant Contact |
NEIL ANDERSON |
Correspondent |
LONDON INTL. LLC. |
2926 COLUMBIA HWY. |
P.O. BOX 8308 |
DOTHAN,
AL
36304
|
|
Correspondent Contact |
NEIL ANDERSON |
Regulation Number | 884.5300
|
Classification Product Code |
|
Date Received | 08/20/1998 |
Decision Date | 11/16/1998 |
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
|
|
|