The following data is part of a premarket notification filed by Origio A/s, A Coopersurgical Company with the FDA for Synvitro Hyadase.
| Device ID | K200680 |
| 510k Number | K200680 |
| Device Name: | Synvitro Hyadase |
| Classification | Media, Reproductive |
| Applicant | Origio A/s, A CooperSurgical Company Knardrupvej 2 Malov, DK 2760 |
| Contact | Monika Bak |
| Correspondent | Monika Bak Origio A/s, A CooperSurgical Company Knardrupvej 2 Malov, DK 2760 |
| Product Code | MQL |
| CFR Regulation Number | 884.6180 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-03-16 |
| Decision Date | 2020-07-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00888937833027 | K200680 | 000 |