Device Classification Name |
Condom
|
510(k) Number |
K980964 |
Device Name |
MAXIMA, TRUSTEX, RIA AND PREMIUM CONDOMS |
Applicant |
LS RUBBER SDN BHD |
2443 FILLMORE ST. |
SUITE 135 |
SAN FRANCISCO,
CA
91115
|
|
Applicant Contact |
MOHAMAD FIRDAOS BIN MOHAMED |
Correspondent |
LS RUBBER SDN BHD |
2443 FILLMORE ST. |
SUITE 135 |
SAN FRANCISCO,
CA
91115
|
|
Correspondent Contact |
MOHAMAD FIRDAOS BIN MOHAMED |
Regulation Number | 884.5300
|
Classification Product Code |
|
Date Received | 03/16/1998 |
Decision Date | 03/12/1999 |
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
|