The following data is part of a premarket notification filed by Fresenius Medical Care Renal Therapies Group, Llc with the FDA for Lilliput Apd System.
| Device ID | K212522 |
| 510k Number | K212522 |
| Device Name: | Lilliput APD System |
| 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 | 2021-08-11 |
| Decision Date | 2022-04-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10840861102614 | K212522 | 000 |
| 00840861102297 | K212522 | 000 |
| 10840861102232 | K212522 | 000 |
| 10840861102225 | K212522 | 000 |
| 10840861102218 | K212522 | 000 |
| 00840861102198 | K212522 | 000 |
| 00840861102280 | K212522 | 000 |