• 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, anti-snoring
510(k) Number K181482
Device Name myTAP2
Applicant
Airway Management, Inc.
3418 Midcourt Road
Carrollton,  TX  75006
Applicant Contact Eric Jarrett
Correspondent
Airway Management, Inc.
3418 Midcourt Road
Carrollton,  TX  75006
Correspondent Contact Paul Dryden
Regulation Number872.5570
Classification Product Code
LRK  
Date Received06/05/2018
Decision Date 08/31/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-