The following data is part of a premarket notification filed by Ypsomed Ag with the FDA for Orbit Infusion Set.
| Device ID | K130468 |
| 510k Number | K130468 |
| Device Name: | ORBIT INFUSION SET |
| Classification | Set, Administration, Intravascular |
| Applicant | YPSOMED AG BRUNNMATTSTRASSE 6 Burgdorf, CH Ch-3401 |
| Contact | Benjamin Reinmann |
| Correspondent | Benjamin Reinmann YPSOMED AG BRUNNMATTSTRASSE 6 Burgdorf, CH Ch-3401 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-02-25 |
| Decision Date | 2013-03-19 |
| Summary: | summary |