The following data is part of a premarket notification filed by Origio A/s with the FDA for Sage 1-step Gm-csf With Hsa, Sage 1-step Gm-csf With Sps.
| Device ID | K172197 |
| 510k Number | K172197 |
| Device Name: | SAGE 1-Step GM-CSF With HSA, SAGE 1-Step GM-CSF With SPS |
| Classification | Media, Reproductive |
| Applicant | ORIGIO A/s Knardrupvej 2 Malov, DK 2760 |
| Contact | Tove Kjaer |
| Correspondent | Tove Kjaer ORIGIO A/s Knardrupvej 2 Malov, DK 2760 |
| Product Code | MQL |
| CFR Regulation Number | 884.6180 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-07-21 |
| Decision Date | 2017-10-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00888937833072 | K172197 | 000 |
| 00888937833058 | K172197 | 000 |