The following data is part of a premarket notification filed by Extracorporeal Medical Specialities, Inc. with the FDA for Triex-ih Dialyzer.
| Device ID | K822738 |
| 510k Number | K822738 |
| Device Name: | TRIEX-IH DIALYZER |
| Classification | Accessories, Blood Circuit, Hemodialysis |
| Applicant | EXTRACORPOREAL MEDICAL SPECIALITIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KOC |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-09-09 |
| Decision Date | 1982-09-24 |