Device Classification Name |
condom with nonoxynol-9
|
510(k) Number |
K981955 |
Device Name |
MAXIMA, TRUSTEX, RIA AND PREMIUM EL LES CONDOMS |
Applicant |
LS RUBBER SDN BHD |
11535 PARK WOODS CIRCLE |
SUITE B |
ALPHARETTA,
GA
30005
|
|
Applicant Contact |
RAJIL VOHRA |
Correspondent |
LS RUBBER SDN BHD |
11535 PARK WOODS CIRCLE |
SUITE B |
ALPHARETTA,
GA
30005
|
|
Correspondent Contact |
RAJIL VOHRA |
Regulation Number | 884.5310
|
Classification Product Code |
|
Date Received | 06/04/1998 |
Decision Date | 03/15/1999 |
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
|
|
|