Device Classification Name |
Condom
|
510(k) Number |
K854247 |
Device Name |
JELLIA SKIN 1001 & LUBRICATED MILLION CONDOMS |
Applicant |
M/S SEOHUNG INDUSTRIAL CO., LTD. |
U.S. HWY. 190 & COLFAX ST. |
P.O. BOX 29 |
CAMERON,
TX
76520
|
|
Applicant Contact |
MICHAEL D KIM |
Correspondent |
M/S SEOHUNG INDUSTRIAL CO., LTD. |
U.S. HWY. 190 & COLFAX ST. |
P.O. BOX 29 |
CAMERON,
TX
76520
|
|
Correspondent Contact |
MICHAEL D KIM |
Regulation Number | 884.5300
|
Classification Product Code |
|
Date Received | 10/21/1985 |
Decision Date | 01/16/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|