Device Classification Name |
Condom
|
510(k) Number |
K945930 |
Device Name |
RIA LATEX CONDOM WITH SPERMICIDE, RIA COLOR CONDOM WITH SPERMICIDE |
Applicant |
LINE ONE LABORATORIES & TRADING CO. |
P.O. BOX 861941 |
LOS ANGELES,
CA
90086
|
|
Applicant Contact |
BUDIMAN LEE |
Correspondent |
LINE ONE LABORATORIES & TRADING CO. |
P.O. BOX 861941 |
LOS ANGELES,
CA
90086
|
|
Correspondent Contact |
BUDIMAN LEE |
Regulation Number | 884.5300
|
Classification Product Code |
|
Date Received | 12/05/1994 |
Decision Date | 12/19/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|