The following data is part of a premarket notification filed by Dravon Medical, Inc. with the FDA for Peritoneal Dialysis Cycler Set (8unit).
| Device ID | K812772 |
| 510k Number | K812772 |
| Device Name: | PERITONEAL DIALYSIS CYCLER SET (8UNIT) |
| Classification | Set, Administration, For Peritoneal Dialysis, Disposable |
| Applicant | DRAVON MEDICAL, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KDJ |
| CFR Regulation Number | 876.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-10-05 |
| Decision Date | 1981-10-19 |