The following data is part of a premarket notification filed by Terumo Medical Corp. with the FDA for Clirans Te08 Hollow Fiber Dialyzer.
| Device ID | K823768 |
| 510k Number | K823768 |
| Device Name: | CLIRANS TE08 HOLLOW FIBER DIALYZER |
| Classification | Unit, Cryophthalmic, Ac-powered |
| Applicant | TERUMO MEDICAL CORP. 125 BLUE BALL RD. Elkton, MD 21921 |
| Product Code | HRN |
| CFR Regulation Number | 886.4170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-12-14 |
| Decision Date | 1983-01-08 |