Device Classification Name |
condom
|
510(k) Number |
K994118 |
Device Name |
OSMANTHUS, KONGFU, AND GOBON, NATURAL RUBBER LATEX CONDOMS |
Applicant |
GUILIN LATEX FACTORY |
93 MORNINGSIDE DR. |
SAN FRANCISCO,
CA
94132
|
|
Applicant Contact |
PETER WEI |
Correspondent |
GUILIN LATEX FACTORY |
93 MORNINGSIDE DR. |
SAN FRANCISCO,
CA
94132
|
|
Correspondent Contact |
PETER WEI |
Regulation Number | 884.5300
|
Classification Product Code |
|
Date Received | 12/06/1999 |
Decision Date | 08/14/2000 |
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
|
Recalls |
CDRH Recalls
|
|
|