The following data is part of a premarket notification filed by Terumo America, Inc. with the FDA for Clirans Te15 Hollow Fiber Dialyzer.
| Device ID | K801193 |
| 510k Number | K801193 |
| Device Name: | CLIRANS TE15 HOLLOW FIBER DIALYZER |
| Classification | Set, Administration, For Peritoneal Dialysis, Disposable |
| Applicant | TERUMO AMERICA, 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 | 1980-05-19 |
| Decision Date | 1980-08-12 |