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 Device, Jaw Repositioning
510(k) Number K191320
Device Name Slow Wave DS8
Applicant
Slow Wave, Inc.
26100 Countryside Dr.
Spicewood,  TX  78669
Applicant Contact Wayne R. Wagner
Correspondent
Slow Wave, Inc.
26100 Countryside Dr.
Spicewood,  TX  78669
Correspondent Contact Wayne R. Wagner
Regulation Number872.5570
Classification Product Code
LQZ  
Subsequent Product Code
LRK  
Date Received05/15/2019
Decision Date 10/02/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-