Device Classification Name |
Condom
|
510(k) Number |
K001883 |
Device Name |
LIFESTYLES, CONTEMPO OR PRIVATE LABEL LARGE CONDOM |
Applicant |
ANSELL HEALTHCARE, INC. |
1500 INDUSTRIAL RD. |
P.O. BOX 1252 |
DOTHAN,
AL
36302
|
|
Applicant Contact |
LON D MCILVAIN |
Correspondent |
ANSELL HEALTHCARE, INC. |
1500 INDUSTRIAL RD. |
P.O. BOX 1252 |
DOTHAN,
AL
36302
|
|
Correspondent Contact |
LON D MCILVAIN |
Regulation Number | 884.5300
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 06/21/2000 |
Decision Date | 07/31/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|