Device Classification Name |
Media, Reproductive
|
510(k) Number |
K080446 |
Device Name |
RAPIDVIT AND RAPIDWARM CLEAVE |
Applicant |
VITROLIFE SWEDEN AB |
FAKTORVAGEN 13 |
KUNGSBACKA,
SE
SE-434 37
|
|
Applicant Contact |
KJELL KJORK |
Correspondent |
VITROLIFE SWEDEN AB |
FAKTORVAGEN 13 |
KUNGSBACKA,
SE
SE-434 37
|
|
Correspondent Contact |
KJELL KJORK |
Regulation Number | 884.6180
|
Classification Product Code |
|
Date Received | 02/19/2008 |
Decision Date | 11/26/2008 |
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 |
Yes
|
|
|