• 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 K132506
Device Name SLEEPTIGHT MOUTHPIECE, SLEEPPRO, QUIETNITE, ALTITUDE MOUTHPIECE, SLEEP EASY
Applicant
MICHAEL D. WILLIAMS,DDS PA
10991 SW 42ND PL
DAVIE,  FL  33328
Applicant Contact MICHAEL D WILLIAMS
Correspondent
MICHAEL D. WILLIAMS,DDS PA
10991 SW 42ND PL
DAVIE,  FL  33328
Correspondent Contact MICHAEL D WILLIAMS
Regulation Number872.5570
Classification Product Code
LRK  
Date Received08/12/2013
Decision Date 05/29/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-