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 K121285
Device Name ORAVAN OSA
Applicant
NEW JERSEY SNORING SOLUTIONS
769 NORTHFIELD AVENUE
SUITE 154
WEST ORANGE,  NJ  07052
Applicant Contact DEBORAH STEIN
Correspondent
NEW JERSEY SNORING SOLUTIONS
769 NORTHFIELD AVENUE
SUITE 154
WEST ORANGE,  NJ  07052
Correspondent Contact DEBORAH STEIN
Regulation Number872.5570
Classification Product Code
LRK  
Date Received04/30/2012
Decision Date 03/08/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-