Device Classification Name |
Condom
|
510(k) Number |
K120394 |
Device Name |
LIFESTYLES ZERO LUBRICATED LATEX CONDOM |
Applicant |
ANSELL HEATHCARE PRODUCTS LLC |
1635 INDUSTRIAL ROAD |
DOTHAN,
AL
36303
|
|
Applicant Contact |
CYNTHIA INGRAM |
Correspondent |
ANSELL HEATHCARE PRODUCTS LLC |
1635 INDUSTRIAL ROAD |
DOTHAN,
AL
36303
|
|
Correspondent Contact |
CYNTHIA INGRAM |
Regulation Number | 884.5300
|
Classification Product Code |
|
Date Received | 02/08/2012 |
Decision Date | 05/08/2012 |
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
|
Recalls |
CDRH Recalls
|
|
|