The following data is part of a premarket notification filed by Tri-med, Inc. with the FDA for Tm-capd.
| Device ID | K812615 |
| 510k Number | K812615 |
| Device Name: | TM-CAPD |
| Classification | Peritoneal Dialysate Filter |
| Applicant | TRI-MED, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KPP |
| CFR Regulation Number | 876.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-09-15 |
| Decision Date | 1982-01-05 |