Device Classification Name |
condom
|
510(k) Number |
K992081 |
Device Name |
VARIOUS ANSELL TRADENAMES OR PRIVATE LABEL |
Applicant |
SURETEX PROPHYLACTICS (INDIA) LTD. |
1500 INDUSTRIAL RD. |
P.O. BOX 1252 |
DOTHAN,
AL
36302
|
|
Applicant Contact |
LON D MCILVAIN |
Correspondent |
SURETEX PROPHYLACTICS (INDIA) LTD. |
1500 INDUSTRIAL RD. |
P.O. BOX 1252 |
DOTHAN,
AL
36302
|
|
Correspondent Contact |
LON D MCILVAIN |
Regulation Number | 884.5300
|
Classification Product Code |
|
Date Received | 06/21/1999 |
Decision Date | 08/19/1999 |
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
|
|
|