The following data is part of a premarket notification filed by Fresenius Medical Care Renal Therapies Group, Llc with the FDA for Liberty Cycler Set.
| Device ID | K173718 |
| 510k Number | K173718 |
| Device Name: | Liberty Cycler Set |
| Classification | System, Peritoneal, Automatic Delivery |
| Applicant | Fresenius Medical Care Renal Therapies Group, LLC 920 Winter Street Waltham, MA 02451 |
| Contact | Denise Oppermann |
| Correspondent | Denise Oppermann Fresenius Medical Care Renal Therapies Group, LLC 920 Winter Street Waltham, MA 02451 |
| Product Code | FKX |
| CFR Regulation Number | 876.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-12-05 |
| Decision Date | 2018-05-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10840861102324 | K173718 | 000 |
| 10840861102317 | K173718 | 000 |
| 10840861102300 | K173718 | 000 |
| 10840861102713 | K173718 | 000 |
| 10840861102706 | K173718 | 000 |