The following data is part of a premarket notification filed by Hemodia S.a.s. with the FDA for Hemodia Arthroscopy Pump Tube Sets (hats).
| Device ID | K132883 |
| 510k Number | K132883 |
| Device Name: | HEMODIA ARTHROSCOPY PUMP TUBE SETS (HATS) |
| Classification | Arthroscope |
| Applicant | HEMODIA S.A.S. 85 DU CHENE VERT Labege, FR 31670 |
| Contact | Remi Teuliere |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2013-09-13 |
| Decision Date | 2013-11-01 |
| Summary: | summary |