The following data is part of a premarket notification filed by Nouvag Ag with the FDA for Tcm Endo Iii.
| Device ID | K013185 |
| 510k Number | K013185 |
| Device Name: | TCM ENDO III |
| Classification | Handpiece, Belt And/or Gear Driven, Dental |
| Applicant | NOUVAG AG 1717 WEST COLLINS AVE. Orange, CA 92867 |
| Contact | Colleen Boswell |
| Correspondent | Colleen Boswell NOUVAG AG 1717 WEST COLLINS AVE. Orange, CA 92867 |
| Product Code | EFA |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-09-24 |
| Decision Date | 2001-11-28 |
| Summary: | summary |