The following data is part of a premarket notification filed by Hemocleanse, Inc. with the FDA for Biologic Dt-1000 Machine.
| Device ID | K923046 |
| 510k Number | K923046 |
| Device Name: | BIOLOGIC DT-1000 MACHINE |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | HEMOCLEANSE, INC. 2701 B KENT AVE. West Lafayette, IN 47906 |
| Contact | Stephen R Ash |
| Correspondent | Stephen R Ash HEMOCLEANSE, INC. 2701 B KENT AVE. West Lafayette, IN 47906 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-06-24 |
| Decision Date | 1994-09-30 |