The following data is part of a premarket notification filed by Maxter Catheters with the FDA for Medicina Enteral Feeding Tubes And Accessories Model Mgx/yy.
| Device ID | K100366 |
| 510k Number | K100366 |
| Device Name: | MEDICINA ENTERAL FEEDING TUBES AND ACCESSORIES MODEL MGX/YY |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | MAXTER CATHETERS VILLAGE D'ENTREPRISES SAINT HENRI II, RUE ANNE GACON Marseille, FR 13016 |
| Contact | M. Bernard Daurelle |
| Correspondent | M. Bernard Daurelle MAXTER CATHETERS VILLAGE D'ENTREPRISES SAINT HENRI II, RUE ANNE GACON Marseille, FR 13016 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-02-12 |
| Decision Date | 2010-06-14 |
| Summary: | summary |