Device Classification Name |
Condom
|
510(k) Number |
K972428 |
Device Name |
EXTRAWEAR, GENTLEMEN'S CHOICE |
Applicant |
CUSTOM SERVICES INTL., INC. |
3111 WEST POST RD. |
LAS VEGAS,
NV
89118
|
|
Applicant Contact |
LILLIE C THOMAS |
Correspondent |
CUSTOM SERVICES INTL., INC. |
3111 WEST POST RD. |
LAS VEGAS,
NV
89118
|
|
Correspondent Contact |
LILLIE C THOMAS |
Regulation Number | 884.5300
|
Classification Product Code |
|
Date Received | 06/27/1997 |
Decision Date | 08/25/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|