The following data is part of a premarket notification filed by Janneck Ent. Of Texas with the FDA for Dialysis, Jet System.
| Device ID | K770331 |
| 510k Number | K770331 |
| Device Name: | DIALYSIS, JET SYSTEM |
| Classification | Reamer, Pulp Canal, Endodontic |
| Applicant | JANNECK ENT. OF TEXAS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | EKP |
| CFR Regulation Number | 872.4565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1977-02-17 |
| Decision Date | 1977-04-20 |