Device Classification Name |
Catheter, Assisted Reproduction
|
510(k) Number |
K162064 |
Device Name |
CrossBay IVF Embryo Transfer Catheter Set |
Applicant |
CrossBay Medical Inc. |
13240 Evening Creek Drive, Suite 304 |
San Diego,
CA
92128
|
|
Applicant Contact |
Piush Vidyarthi |
Correspondent |
Domecus Consulting Services, LLC |
1171 Barroihet Drive |
Hillsborough,
CA
94010
|
|
Correspondent Contact |
Cindy Domecus |
Regulation Number | 884.6110
|
Classification Product Code |
|
Date Received | 07/26/2016 |
Decision Date | 01/05/2017 |
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
|
|
|