Device Classification Name |
catheter, assisted reproduction
|
510(k) Number |
K172051 |
Device Name |
Guardia™ Access Nano and Soft-Trans Embryo Transfer Catheter Sets, Soft-Trans Embryo Transfer Catheter, Soft-Trans Guide Catheter |
Applicant |
Cook Incorporated |
750 Daniels Way, P.O. Box 489 |
Bloomington,
IN
47402
|
|
Applicant Contact |
Naomi Funkhouser |
Correspondent |
Cook Incorporated |
750 Daniels Way, P.O. Box 489 |
Bloomington,
IN
47402
|
|
Correspondent Contact |
Naomi Funkhouser |
Regulation Number | 884.6110
|
Classification Product Code |
|
Date Received | 07/06/2017 |
Decision Date | 01/10/2018 |
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
|
|
|