The following data is part of a premarket notification filed by Nouvag Ag with the FDA for Tcm Endo V, Model 1534.
| Device ID | K042822 |
| 510k Number | K042822 |
| Device Name: | TCM ENDO V, MODEL 1534 |
| Classification | Handpiece, Direct Drive, Ac-powered |
| Applicant | NOUVAG AG REUSSWEHRSTRASSE 1 Gebenstorf, CH 5412 |
| Contact | Erich Forster |
| Correspondent | Erich Forster NOUVAG AG REUSSWEHRSTRASSE 1 Gebenstorf, CH 5412 |
| Product Code | EKX |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-10-12 |
| Decision Date | 2004-12-22 |
| Summary: | summary |