The following data is part of a premarket notification filed by Disetronic Medical Systems Ag with the FDA for Accu-chek Ultraflex Infusion Set.
| Device ID | K070189 |
| 510k Number | K070189 |
| Device Name: | ACCU-CHEK ULTRAFLEX INFUSION SET |
| Classification | Set, Administration, Intravascular |
| Applicant | DISETRONIC MEDICAL SYSTEMS AG 9115 Hague Road Indianapolis, IN 46250 |
| Contact | Mike Flis |
| Correspondent | Mike Flis DISETRONIC MEDICAL SYSTEMS AG 9115 Hague Road Indianapolis, IN 46250 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-01-22 |
| Decision Date | 2007-02-21 |
| Summary: | summary |