Device Classification Name |
Labware, Assisted Reproduction
|
510(k) Number |
K162640 |
Device Name |
iVitri EZ |
Applicant |
REPROBITECH CORP. |
27 HADDON RD |
New Hyde Park,
NY
11040
|
|
Applicant Contact |
Huai L. Feng |
Correspondent |
REPROBITECH CORP. |
42-31 Colden Street, Suite 202 |
Flushing,
NY
11355
|
|
Correspondent Contact |
Huai L. Feng |
Regulation Number | 884.6160
|
Classification Product Code |
|
Date Received | 09/22/2016 |
Decision Date | 06/30/2017 |
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
|
|
|