The following data is part of a premarket notification filed by Origio A/s with the FDA for Origio Gradient 100, Origio Gradient 90, Origio Gradient 40/80, Origio Sperm Wash.
| Device ID | K153267 |
| 510k Number | K153267 |
| Device Name: | ORIGIO Gradient 100, ORIGIO Gradient 90, ORIGIO Gradient 40/80, ORIGIO Sperm Wash |
| 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 | 2015-11-12 |
| Decision Date | 2016-07-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 60888937816886 | K153267 | 000 |
| 60888937816879 | K153267 | 000 |
| 60888937816862 | K153267 | 000 |
| 20888937816901 | K153267 | 000 |
| 20888937816840 | K153267 | 000 |
| 00888937816891 | K153267 | 000 |
| 00888937816853 | K153267 | 000 |
| 00888937816822 | K153267 | 000 |