Device Classification Name |
condom
|
510(k) Number |
K032124 |
Device Name |
DUREX PLAY LUBRICANT |
Applicant |
SSL AMERICAS, INC. |
3585 ENGINEERING DR. |
SUITE 200 |
NORCROSS,
GA
30092
|
|
Applicant Contact |
KATHLEEN HARRIS |
Correspondent |
SSL AMERICAS, INC. |
3585 ENGINEERING DR. |
SUITE 200 |
NORCROSS,
GA
30092
|
|
Correspondent Contact |
KATHLEEN HARRIS |
Regulation Number | 884.5300
|
Classification Product Code |
|
Date Received | 07/10/2003 |
Decision Date | 01/16/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|