The following data is part of a premarket notification filed by Terumo Medical Corp. with the FDA for Clirans Wet Pack Hollow Fiber Dialyzer.
| Device ID | K930503 |
| 510k Number | K930503 |
| Device Name: | CLIRANS WET PACK HOLLOW FIBER DIALYZER |
| Classification | Dialyzer, Capillary, Hollow Fiber |
| Applicant | TERUMO MEDICAL CORP. P.O. BOX 605 Elkton, MD 21912 |
| Contact | Alan B Hershman |
| Correspondent | Alan B Hershman TERUMO MEDICAL CORP. P.O. BOX 605 Elkton, MD 21912 |
| Product Code | FJI |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-02-01 |
| Decision Date | 1995-03-06 |