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 K112766
Device Name SNORKEL
Applicant
Fellmar Company
2670 S Myrtle Ave. #106
Monrovia,  CA  91016
Applicant Contact WAYNE MARSHALL
Correspondent
Fellmar Company
2670 S Myrtle Ave. #106
Monrovia,  CA  91016
Correspondent Contact WAYNE MARSHALL
Regulation Number872.5570
Classification Product Code
LQZ  
Date Received09/22/2011
Decision Date 06/04/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-