The following data is part of a premarket notification filed by American Medical Products, Inc. with the FDA for Peritoneal Dialysis Cycler Set.
| Device ID | K813069 |
| 510k Number | K813069 |
| Device Name: | PERITONEAL DIALYSIS CYCLER SET |
| Classification | Set, Administration, For Peritoneal Dialysis, Disposable |
| Applicant | AMERICAN MEDICAL PRODUCTS, 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 | 1981-10-30 |
| Decision Date | 1981-11-16 |