Device Classification Name |
condom
|
510(k) Number |
K970792 |
Device Name |
INNERWEAR/EXTRAWEAR/JIMMY-O RAINCOAT/ZEUS/GENTLEMEN'S CHOICE |
Applicant |
TITAN CONDOMS |
3111 WEST POST RD. |
LAS VEGAS,
NV
89118
|
|
Applicant Contact |
LILLIE C THOMAS |
Correspondent |
TITAN CONDOMS |
3111 WEST POST RD. |
LAS VEGAS,
NV
89118
|
|
Correspondent Contact |
LILLIE C THOMAS |
Regulation Number | 884.5300
|
Classification Product Code |
|
Date Received | 03/04/1997 |
Decision Date | 06/02/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|