Device Classification Name |
Cannula, Intrauterine Insemination
|
510(k) Number |
K921518 |
Device Name |
LIFETEK IUI CATHETER |
Applicant |
LIFETEK MEDICAL, INC. |
100 W. NORTH ST. |
DEFOREST,
WI
53532
|
|
Applicant Contact |
MICHAEL KVALO |
Correspondent |
LIFETEK MEDICAL, INC. |
100 W. NORTH ST. |
DEFOREST,
WI
53532
|
|
Correspondent Contact |
MICHAEL KVALO |
Regulation Number | 884.5250
|
Classification Product Code |
|
Date Received | 03/31/1992 |
Decision Date | 05/10/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|