Device Classification Name |
condom
|
510(k) Number |
K072747 |
Device Name |
UNIDUS MAGNUM MALE LATEX CONDOM |
Applicant |
UNIDUS CORP. |
507 SHALLOW CREEK ROAD |
TUSCALOOSA,
AL
35406
|
|
Applicant Contact |
CLAUDE L WRIGHT |
Correspondent |
UNIDUS CORP. |
507 SHALLOW CREEK ROAD |
TUSCALOOSA,
AL
35406
|
|
Correspondent Contact |
CLAUDE L WRIGHT |
Regulation Number | 884.5300
|
Classification Product Code |
|
Date Received | 09/27/2007 |
Decision Date | 11/15/2007 |
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
|
|
|