Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name stimulator, nerve, transcutaneous, over-the-counter
510(k) Number K162392
Device Name Avazzia
Applicant
AVAZZIA, INC.
13140 COIT ROAD
SUITE 515
DALLAS,  TX  75240
Applicant Contact TAMMY LAHUTSKY
Correspondent
AVAZZIA, INC.
13140 COIT ROAD
SUITE 515
DALLAS,  TX  75240
Correspondent Contact TAMMY LAHUTSKY
Regulation Number882.5890
Classification Product Code
NUH  
Subsequent Product Code
GZJ  
Date Received08/26/2016
Decision Date 05/12/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-