Device Classification Name |
Catheter, Assisted Reproduction
|
510(k) Number |
K191015 |
Device Name |
Soft-Pass Embryo Mock Transfer Catheter Sets (Soft-Pass Embryo Mock Transfer Catheter Set and Soft-Pass Embryo Mock Transfer Catheter Set with Echogenic Tip) |
Applicant |
Cook Incorporated |
750 Daniels Way P.O. Box 489 |
Bloomington,
IN
47402
|
|
Applicant Contact |
Ian Herrman |
Correspondent |
Cook Incorporated |
750 Daniels Way P.O. Box 489 |
Bloomington,
IN
47402
|
|
Correspondent Contact |
Ian Herrman |
Regulation Number | 884.6110
|
Classification Product Code |
|
Date Received | 04/17/2019 |
Decision Date | 05/17/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|