Device Classification Name |
media, reproductive
|
510(k) Number |
K173731 |
Device Name |
SAGE Vitrification Kit (ART-8025 and ART-8026) / SAGE Vitrification Warming Kit (ART-8030 and ART-8031) |
Applicant |
CooperSurgical, Inc |
95 Corporate Dr. |
Trumbull,
CT
06611
|
|
Applicant Contact |
Tove Kjaer |
Correspondent |
Origio a/s |
Knardrupvej 2 |
Malov,
DK
06611
|
|
Correspondent Contact |
Tove Kjaer |
Regulation Number | 884.6180
|
Classification Product Code |
|
Date Received | 12/06/2017 |
Decision Date | 03/02/2018 |
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
|
|
|