The following data is part of a premarket notification filed by Coopersurgical, Inc with the FDA for Sage Vitrification Kit (art-8025 And Art-8026) / Sage Vitrification Warming Kit (art-8030 And Art-8031).
| Device ID | K173731 |
| 510k Number | K173731 |
| Device Name: | SAGE Vitrification Kit (ART-8025 And ART-8026) / SAGE Vitrification Warming Kit (ART-8030 And ART-8031) |
| Classification | Media, Reproductive |
| Applicant | CooperSurgical, Inc 95 Corporate Dr. Trumbull, CT 06611 |
| Contact | Tove Kjaer |
| Correspondent | Tove Kjaer Origio A/s Knardrupvej 2 Malov, DK 06611 |
| Product Code | MQL |
| CFR Regulation Number | 884.6180 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-12-06 |
| Decision Date | 2018-03-02 |
| Summary: | summary |