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 sleep appliances with patient monitoring
510(k) Number K170606
Device Name Acrylic Herbst Appliance with Micro-Recorder
Applicant
Gergen's Orthodontic Lab
1745 West Deer Valley Rd, Suite 112
Phoenix,  AZ  85027
Applicant Contact Chris Morrison
Correspondent
BackRoads Consulting
PO Box 566
Chesterland,  OH  44026 *0566
Correspondent Contact Karen E. Warden
Regulation Number872.5570
Classification Product Code
PLC  
Date Received03/01/2017
Decision Date 11/16/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-