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 K112205
FOIA Releasable 510(k) K112205
Device Name SNORERX 9.0
Applicant
Consumer Health Products, Inc.
49 Coastal Oak
Alsio Viejo,  CA  92656
Applicant Contact GARY MOCNIK
Correspondent
Consumer Health Products, Inc.
49 Coastal Oak
Alsio Viejo,  CA  92656
Correspondent Contact GARY MOCNIK
Regulation Number872.5570
Classification Product Code
LRK  
Date Received08/01/2011
Decision Date 11/16/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-