Device Classification Name |
System, Assisted Reproduction Laser
|
510(k) Number |
K192008 |
Device Name |
LaserShot M, NaviLase |
Applicant |
Vitrolife GmbH |
Dr. -Pauling-Str.9 |
Bruckberg,
DE
84079
|
|
Applicant Contact |
Susanne Schweitzer |
Correspondent |
Vitrolife GmbH |
Dr. -Pauling-Str.9 |
Bruckberg,
DE
84079
|
|
Correspondent Contact |
Susanne Schweitzer |
Regulation Number | 884.6200
|
Classification Product Code |
|
Date Received | 07/29/2019 |
Decision Date | 03/25/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|