Device Classification Name |
media, reproductive
|
510(k) Number |
K190152 |
Device Name |
Vit Kit- Freeze NX and Vit Kit- Warm NX |
Applicant |
FUJIFILM Irvine Scientific, Inc. |
2511 Daimler Street |
Santa Ana,
CA
92705
|
|
Applicant Contact |
Jayme Yamaguchi-Owens |
Correspondent |
FUJIFILM Irine Scientific, Inc. |
2511 Daimler Street |
Santa Ana,
CA
92705
|
|
Correspondent Contact |
Jayme Yamaguchi-Owens |
Regulation Number | 884.6180
|
Classification Product Code |
|
Date Received | 01/30/2019 |
Decision Date | 06/21/2019 |
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
|
|
|