The following data is part of a premarket notification filed by B. Braun Avitum Ag with the FDA for Dialog With Adimea Option.
| Device ID | K083460 |
| 510k Number | K083460 |
| Device Name: | DIALOG WITH ADIMEA OPTION |
| Classification | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
| Applicant | B. BRAUN AVITUM AG 901 MARCON BOULEVARD Allentown, PA 18109 |
| Contact | Bonnie Kincaid, Rac |
| Correspondent | Bonnie Kincaid, Rac B. BRAUN AVITUM AG 901 MARCON BOULEVARD Allentown, PA 18109 |
| Product Code | KDI |
| CFR Regulation Number | 876.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-11-21 |
| Decision Date | 2010-02-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04046964966149 | K083460 | 000 |
| 04039239070467 | K083460 | 000 |
| 04039239070450 | K083460 | 000 |
| 04039239070443 | K083460 | 000 |
| 04039239070436 | K083460 | 000 |
| 04039239041733 | K083460 | 000 |
| 04039239040859 | K083460 | 000 |
| 04039239040743 | K083460 | 000 |
| 04039239040729 | K083460 | 000 |
| 04046964285615 | K083460 | 000 |
| 04046964285608 | K083460 | 000 |
| 04046963686345 | K083460 | 000 |
| 04039239070474 | K083460 | 000 |
| 04046963686680 | K083460 | 000 |
| 04046964762734 | K083460 | 000 |
| 04046964738388 | K083460 | 000 |
| 04046964091827 | K083460 | 000 |
| 04046964091728 | K083460 | 000 |
| 04046964057434 | K083460 | 000 |
| 04046963816605 | K083460 | 000 |
| 04046963686772 | K083460 | 000 |
| 04046963686734 | K083460 | 000 |
| 04046963686727 | K083460 | 000 |
| 04046963686710 | K083460 | 000 |
| 04046963686697 | K083460 | 000 |
| 04046963686338 | K083460 | 000 |