Device Classification Name |
media, reproductive
|
510(k) Number |
K160863 |
Device Name |
PBS(-), Phosphate Buffered Saline |
Applicant |
KITAZATO BIOPHARMA CO., LTD. |
81 NAKIJIMA |
FUJI,
JP
416-0907
|
|
Applicant Contact |
FUTOSHI INOUE |
Correspondent |
EMERGO GLOBAL CONSULTING, LLC |
816 CONGRESS AVENUE, 1400 |
AUSTIN,
TX
78701
|
|
Correspondent Contact |
DIANE SUDDUTH |
Regulation Number | 884.6180
|
Classification Product Code |
|
Date Received | 03/29/2016 |
Decision Date | 07/28/2016 |
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
|
|
|