Device Classification Name |
Needle, Assisted Reproduction
|
510(k) Number |
K172050 |
Device Name |
Follicle Aspiration Set, Reduced Single Lumen |
Applicant |
Vitrolife Sweden AB |
Gustaf Werners gata 2 |
Vastra Frolunda,
SE
SE-42132
|
|
Applicant Contact |
Anja Bengtzelius |
Correspondent |
Regulatory Specialist, Inc. |
3722 Ave. Sausalito |
Irvine,
CA
92606
|
|
Correspondent Contact |
Greg Holland |
Regulation Number | 884.6100
|
Classification Product Code |
|
Date Received | 07/06/2017 |
Decision Date | 11/21/2017 |
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
|
|
|