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, Jaw Repositioning
510(k) Number K922818
Device Name SNORE-NO-MORE
Applicant
Great Lakes Orthodontics, Ltd.
199 Fire Tower Dr.
P.O. Box 5111
Tonawanda,  NY  14151
Applicant Contact JAMES R KUNKEMOLLER
Correspondent
Great Lakes Orthodontics, Ltd.
199 Fire Tower Dr.
P.O. Box 5111
Tonawanda,  NY  14151
Correspondent Contact JAMES R KUNKEMOLLER
Regulation Number872.5570
Classification Product Code
LQZ  
Date Received06/11/1992
Decision Date 02/09/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-