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 K163580
Device Name ASD Oral Appliances
Applicant
AMERICAN SLEEP DENTISTRY
1957 WEST ROYAL HUNTE DRIVE
STE 250
CEDAR CITY,  UT  84720 -1903
Applicant Contact RYAN GREGERSON
Correspondent
AMERICAN SLEEP DENTISTRY
1957 WEST ROYAL HUNTE DRIVE
STE 250
CEDAR CITY,  UT  84720 -1903
Correspondent Contact RYAN GREGERSON
Regulation Number872.5570
Classification Product Code
LRK  
Date Received12/20/2016
Decision Date 06/08/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-