The following data is part of a premarket notification filed by Origio A/s with the FDA for Transem And Echogen Embryo Transfer Catheters.
| Device ID | K161547 |
| 510k Number | K161547 |
| Device Name: | Transem And EchoGen Embryo Transfer Catheters |
| Classification | Catheter, Assisted Reproduction |
| Applicant | ORIGIO A/S KNARDRUPVEJ 2 Maaloev, DK 2760 |
| Contact | Tove Kjaer |
| Correspondent | Tove Kjaer ORIGIO A/S KNARDRUPVEJ 2 Maaloev, DK 2760 |
| Product Code | MQF |
| CFR Regulation Number | 884.6110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-06-03 |
| Decision Date | 2017-03-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20888937972799 | K161547 | 000 |
| 20888937972379 | K161547 | 000 |
| 20888937972362 | K161547 | 000 |
| 20888937972355 | K161547 | 000 |
| 20888937972348 | K161547 | 000 |