Device Classification Name |
condom, synthetic
|
510(k) Number |
K072169 |
Device Name |
DUREX SYNTHETIC POLYISOPRENE MALE CONDOM |
Applicant |
SSL AMERICAS, INC. |
3585 ENGINEERING DR. |
SUITE 200 |
NORCROSS,
GA
30092
|
|
Applicant Contact |
CHRIS ROBINSON |
Correspondent |
SSL AMERICAS, INC. |
3585 ENGINEERING DR. |
SUITE 200 |
NORCROSS,
GA
30092
|
|
Correspondent Contact |
CHRIS ROBINSON |
Regulation Number | 884.5300
|
Classification Product Code |
|
Date Received | 08/06/2007 |
Decision Date | 06/19/2008 |
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
|
|
|