The following data is part of a premarket notification filed by Terumo Medical Corp. with the FDA for Clirans T-series Hollow Fiber Dialyzers.
| Device ID | K970708 |
| 510k Number | K970708 |
| Device Name: | CLIRANS T-SERIES HOLLOW FIBER DIALYZERS |
| Classification | Dialyzer, Capillary, Hollow Fiber |
| Applicant | TERUMO MEDICAL CORP. 125 BLUE BALL RD. Elkton, MD 21921 |
| Contact | Keith M Smith |
| Correspondent | Keith M Smith TERUMO MEDICAL CORP. 125 BLUE BALL RD. Elkton, MD 21921 |
| Product Code | FJI |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-02-26 |
| Decision Date | 1997-12-19 |
| Summary: | summary |