The following data is part of a premarket notification filed by Roche Diagnostics Gmbh with the FDA for Accu-chek Flexlink Plus Infusion Set.
| Device ID | K143446 |
| 510k Number | K143446 |
| Device Name: | Accu-Chek FlexLink Plus Infusion Set |
| Classification | Set, Administration, Intravascular |
| Applicant | Roche Diagnostics GmbH Sandhofer Strasse 116 Mannheim, DE 68305 |
| Contact | Alexander Ruegner |
| Correspondent | Alexander Ruegner Roche Diagnostics GmbH Sandhofer Strasse 116 Mannheim, DE 68305 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-12-02 |
| Decision Date | 2015-08-13 |
| Summary: | summary |