Device Classification Name |
condom
|
510(k) Number |
K031369 |
Device Name |
MERCATOR HEALTHCARE MALE LATEX CONDOM |
Applicant |
MERCATOR HEALTHCARE LTD. |
1219 LITTLE CREEK RD. |
DURHAM,
NC
27713
|
|
Applicant Contact |
ELI J CARTER |
Correspondent |
MERCATOR HEALTHCARE LTD. |
1219 LITTLE CREEK RD. |
DURHAM,
NC
27713
|
|
Correspondent Contact |
ELI J CARTER |
Regulation Number | 884.5300
|
Classification Product Code |
|
Date Received | 04/30/2003 |
Decision Date | 10/31/2003 |
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
|
|
|