The following data is part of a premarket notification filed by Disetronic Medical Systems Ag with the FDA for Accu-chek Flexlink Plus Infusion Set, Accu-check Linkassist Plus Insertion Device.
| Device ID | K100704 |
| 510k Number | K100704 |
| Device Name: | ACCU-CHEK FLEXLINK PLUS INFUSION SET, ACCU-CHECK LINKASSIST PLUS INSERTION DEVICE |
| Classification | Pump, Infusion |
| Applicant | DISETRONIC MEDICAL SYSTEMS AG 9115 Hague Road Indianapolis, IN 46250 -0457 |
| Contact | Scott Thiel |
| Correspondent | Scott Thiel DISETRONIC MEDICAL SYSTEMS AG 9115 Hague Road Indianapolis, IN 46250 -0457 |
| Product Code | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-03-12 |
| Decision Date | 2010-05-14 |
| Summary: | summary |