The following data is part of a premarket notification filed by Coopersurgical Inc with the FDA for Sage Vitrification Kit And Sage Vitrification Warming Kit.
| Device ID | K170560 |
| 510k Number | K170560 |
| Device Name: | SAGE Vitrification Kit And SAGE Vitrification Warming Kit |
| Classification | Media, Reproductive |
| Applicant | CooperSurgical Inc 95 Corporate Drive Trumbull, CT 06611 |
| Contact | Tove Kjær |
| Correspondent | Tove Kjær Origio A/S 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 | 2017-02-27 |
| Decision Date | 2017-04-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 60888937830486 | K170560 | 000 |
| 60888937830448 | K170560 | 000 |
| 60888937027138 | K170560 | 000 |
| 20888937027994 | K170560 | 000 |