The following data is part of a premarket notification filed by American Medical Products, Inc. with the FDA for Set, Administration, Manual, Dialysis.
| Device ID | K780957 |
| 510k Number | K780957 |
| Device Name: | SET, ADMINISTRATION, MANUAL, DIALYSIS |
| 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 | 1978-06-12 |
| Decision Date | 1978-07-06 |