Device Classification Name |
extractor, vacuum, fetal
|
510(k) Number |
K981260 |
Device Name |
KIWI SOFT CUP WITH PALM PUMP MODEL NUMBER VFE-6000S, KIWI MUSHROOM CUP WITH PALM PUMP MODEL VFE-6000M |
Applicant |
CLINICAL INNOVATIONS, INC. |
6477 SOUTH COTTONWOOD ST. |
MURRAY,
UT
84107
|
|
Applicant Contact |
WM D WALLACE |
Correspondent |
CLINICAL INNOVATIONS, INC. |
6477 SOUTH COTTONWOOD ST. |
MURRAY,
UT
84107
|
|
Correspondent Contact |
WM D WALLACE |
Regulation Number | 884.4340
|
Classification Product Code |
|
Date Received | 04/06/1998 |
Decision Date | 09/22/1998 |
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
|
|
|