Device Classification Name |
Condom
|
510(k) Number |
K090259 |
Device Name |
OKAMOTO ULTRA THIN |
Applicant |
OKAMOTO U.S.A., INC. |
700 THIRTEENTH STREET, N.W. |
SUITE 1200 |
WASHINGTON,
DC
20005
|
|
Applicant Contact |
JEFFERY N GIBBS |
Correspondent |
OKAMOTO U.S.A., INC. |
700 THIRTEENTH STREET, N.W. |
SUITE 1200 |
WASHINGTON,
DC
20005
|
|
Correspondent Contact |
JEFFERY N GIBBS |
Regulation Number | 884.5300
|
Classification Product Code |
|
Date Received | 02/02/2009 |
Decision Date | 03/31/2009 |
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
|
|
|