Device Classification Name |
condom
|
510(k) Number |
K032909 |
Device Name |
THAI NIPPON EXTRA STRENGTH MALE LATEX CONDOM |
Applicant |
THAI NIPPON RUBBER INDUSTRY CO., LTD. |
1219 LITTLE CREEK RD. |
DURHAM,
NC
27713
|
|
Applicant Contact |
ELI J CARTER |
Correspondent |
THAI NIPPON RUBBER INDUSTRY CO., LTD. |
1219 LITTLE CREEK RD. |
DURHAM,
NC
27713
|
|
Correspondent Contact |
ELI J CARTER |
Regulation Number | 884.5300
|
Classification Product Code |
|
Date Received | 09/17/2003 |
Decision Date | 12/16/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|