The following data is part of a premarket notification filed by Toray Industries (america), Inc. with the FDA for Hemofeel-ch, Models Ch-0.35l, Ch-0.6l, Ch-1.0l.
| Device ID | K994198 |
| 510k Number | K994198 |
| Device Name: | HEMOFEEL-CH, MODELS CH-0.35L, CH-0.6L, CH-1.0L |
| Classification | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
| Applicant | TORAY INDUSTRIES (AMERICA), INC. 540 COLLEGE ST. Bellaire, TX 77401 -5010 |
| Contact | Lisa S Jones |
| Correspondent | Lisa S Jones TORAY INDUSTRIES (AMERICA), INC. 540 COLLEGE ST. Bellaire, TX 77401 -5010 |
| Product Code | KDI |
| CFR Regulation Number | 876.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-12-13 |
| Decision Date | 2000-08-25 |
| Summary: | summary |