Device Classification Name |
media, reproductive
|
510(k) Number |
K183486 |
Device Name |
RapidVit™ Oocyte, RapidWarm™ Oocyte |
Applicant |
Vitrolife Sweden AB |
Gustaf Werners gata 2 |
Vastra Frolunda,
SE
421 32
|
|
Applicant Contact |
Nina Arvidsson |
Correspondent |
Vitrolife Sweden AB |
Gustaf Werners gata 2 |
Vastra Frolunda,
SE
421 32
|
|
Correspondent Contact |
Nina Arvidsson |
Regulation Number | 884.6180
|
Classification Product Code |
|
Date Received | 12/17/2018 |
Decision Date | 07/26/2019 |
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
|
|
|