The following data is part of a premarket notification filed by Addent, Inc. with the FDA for Compex Hd.
| Device ID | K182017 |
| 510k Number | K182017 |
| Device Name: | Compex HD |
| Classification | Composite Resin Warmer |
| Applicant | AdDent, Inc. 43 Miry Brook Road Danbury, CT 06810 |
| Contact | Joshua Friedman |
| Correspondent | Joshua Friedman AdDent, Inc. 43 Miry Brook Road Danbury, CT 06810 |
| Product Code | QGO |
| CFR Regulation Number | 872.6100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-07-27 |
| Decision Date | 2019-04-29 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() COMPEX HD 87627898 5650593 Live/Registered |
Friedman, Joshua 2017-09-29 |