Device Classification Name |
condom with nonoxynol-9
|
510(k) Number |
K003375 |
Device Name |
CONTROL MALE CONDOMS OF NATURAL RUBBER LATEX |
Applicant |
TECNILATEX S.A. |
APDO. CORREOS, 156 |
C/FRAGUAS, 2 ALCORCON |
MADRID,
ES
28923
|
|
Applicant Contact |
JOSE M VAZQUEZ MARTIN |
Correspondent |
TECNILATEX S.A. |
APDO. CORREOS, 156 |
C/FRAGUAS, 2 ALCORCON |
MADRID,
ES
28923
|
|
Correspondent Contact |
JOSE M VAZQUEZ MARTIN |
Regulation Number | 884.5310
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 10/30/2000 |
Decision Date | 01/28/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|