Device Classification Name |
cannula, intrauterine insemination
|
510(k) Number |
K905764 |
Device Name |
SEMINOR |
Applicant |
PROMEDEX, INC. |
C/O RICHARD HAMER ASSOC., INC. |
P.O. BOX 16598 |
FT. WORTH,
TX
76162
|
|
Applicant Contact |
RICHARD A HAMER |
Correspondent |
PROMEDEX, INC. |
C/O RICHARD HAMER ASSOC., INC. |
P.O. BOX 16598 |
FT. WORTH,
TX
76162
|
|
Correspondent Contact |
RICHARD A HAMER |
Regulation Number | 884.5250
|
Classification Product Code |
|
Date Received | 12/27/1990 |
Decision Date | 03/12/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|