The following data is part of a premarket notification filed by Avazzia, Inc. with the FDA for Avazzia.
Device ID | K162392 |
510k Number | K162392 |
Device Name: | Avazzia |
Classification | Stimulator, Nerve, Transcutaneous, Over-the-counter |
Applicant | AVAZZIA, INC. 13140 COIT ROAD SUITE 515 Dallas, TX 75240 |
Contact | Tammy Lahutsky |
Correspondent | Tammy Lahutsky AVAZZIA, INC. 13140 COIT ROAD SUITE 515 Dallas, TX 75240 |
Product Code | NUH |
CFR Regulation Number | 882.5890 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2016-08-26 |
Decision Date | 2017-05-12 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
AVAZZIA 87915894 5654081 Live/Registered |
Avazzia, Inc. 2018-05-10 |