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 |