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, Anti-Snoring
510(k) Number K013049
Device Name NORAD, NOCTURNAL ORAL AIRWAY DILATOR APPLIANCE
Applicant
DENNIS R. BAILEY, DDS
7901 EAST BELLEVIEW AVE.
SUITE 200
ENGLEWOOD,  CO  80111
Applicant Contact DENNIS R BAILEY
Correspondent
DENNIS R. BAILEY, DDS
7901 EAST BELLEVIEW AVE.
SUITE 200
ENGLEWOOD,  CO  80111
Correspondent Contact DENNIS R BAILEY
Regulation Number872.5570
Classification Product Code
LRK  
Date Received09/11/2001
Decision Date 11/29/2001
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
-
-