Device Classification Name |
condom
|
510(k) Number |
K050360 |
Device Name |
TULIP CONDOM |
Applicant |
SHANGHAI LATEX FACTORY |
1700 HUANG XING ROAD |
SHANGHAI,
CN
200433
|
|
Applicant Contact |
LOU JI |
Correspondent |
TUV AMERICA, INC. |
1775 OLD HIGHWAY 8 |
NEW BRIGHTON,
MN
55112 -1891
|
|
Correspondent Contact |
LAURA L DANIELSON |
Regulation Number | 884.5300
|
Classification Product Code |
|
Date Received | 02/14/2005 |
Decision Date | 03/01/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|