Device Classification Name |
Condom
|
510(k) Number |
K000408 |
Device Name |
LIFESTYLES, CONTEMPO OR PRIVATE LABEL STRAWBERRY, VANILLA, OR BANANA FLAVORED CONDOM |
Applicant |
SURETEX PROPHYLACTICS LTD. |
1500 INDUSTRIAL RD. |
P.O. 1252 |
DOTHAN,
AL
36302
|
|
Applicant Contact |
LON D MCINVAIN |
Correspondent |
SURETEX PROPHYLACTICS LTD. |
1500 INDUSTRIAL RD. |
P.O. 1252 |
DOTHAN,
AL
36302
|
|
Correspondent Contact |
LON D MCINVAIN |
Regulation Number | 884.5300
|
Classification Product Code |
|
Date Received | 02/08/2000 |
Decision Date | 04/19/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|