The following data is part of a premarket notification filed by Hemodia Sas with the FDA for Doubleflo System.
| Device ID | K203480 |
| 510k Number | K203480 |
| Device Name: | DOUBLEFLO System |
| Classification | Arthroscope |
| Applicant | Hemodia SAS 85 Rue Du Chene Vert Lebege, FR 31670 |
| Contact | Adeline Theron |
| Correspondent | Arne Briest Visamed GmbH Kastellstr. 8 Karlsruhe, DE 76227 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-11-27 |
| Decision Date | 2021-04-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03661379196069 | K203480 | 000 |
| 03661379196007 | K203480 | 000 |
| 03661379195987 | K203480 | 000 |
| 23661379195530 | K203480 | 000 |
| 23661379195523 | K203480 | 000 |
| 23661379195509 | K203480 | 000 |
| 23661379195493 | K203480 | 000 |
| 03661379200414 | K203480 | 000 |
| 03661379195994 | K203480 | 000 |