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 K973038
Device Name ADJUSTABLE THERASNORE
Applicant
Distar, Inc.
214 W. Cork St.
Winchester,  VA  22601 -4136
Applicant Contact STEPHEN A BROWN
Correspondent
Distar, Inc.
214 W. Cork St.
Winchester,  VA  22601 -4136
Correspondent Contact STEPHEN A BROWN
Regulation Number872.5570
Classification Product Code
LRK  
Date Received08/14/1997
Decision Date 11/12/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-