Device Classification Name |
media, reproductive
|
510(k) Number |
K200680 |
Device Name |
Synvitro Hyadase |
Applicant |
Origio a/s, a CooperSurgical Company |
Knardrupvej 2 |
Malov,
DK
2760
|
|
Applicant Contact |
Monika Bak |
Correspondent |
Origio a/s, a CooperSurgical Company |
Knardrupvej 2 |
Malov,
DK
2760
|
|
Correspondent Contact |
Monika Bak |
Regulation Number | 884.6180
|
Classification Product Code |
|
Date Received | 03/16/2020 |
Decision Date | 07/17/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|