The following data is part of a premarket notification filed by Disetronic Medical Systems Ag with the FDA for Ultraflex Infusion Set.
| Device ID | K033892 |
| 510k Number | K033892 |
| Device Name: | ULTRAFLEX INFUSION SET |
| Classification | Set, Administration, Intravascular |
| Applicant | DISETRONIC MEDICAL SYSTEMS AG KIRCHBERSTRASSE 190, POSTFACH Burgdorf, SE Ch-3401 |
| Contact | Bernd Henningsen |
| Correspondent | Bernd Henningsen DISETRONIC MEDICAL SYSTEMS AG KIRCHBERSTRASSE 190, POSTFACH Burgdorf, SE Ch-3401 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-12-16 |
| Decision Date | 2004-03-09 |
| Summary: | summary |