The following data is part of a premarket notification filed by Norton Performance Plastics Corp. with the FDA for Continuous Ambulatory Dialysis (capd).
| Device ID | K791512 |
| 510k Number | K791512 |
| Device Name: | CONTINUOUS AMBULATORY DIALYSIS (CAPD) |
| Classification | Set, Administration, For Peritoneal Dialysis, Disposable |
| Applicant | NORTON PERFORMANCE PLASTICS CORP. 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 | 1979-07-20 |
| Decision Date | 1980-02-06 |