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 Mouthguard, Prescription
510(k) Number K014079
Device Name DR. HAYS BITE GUARD
Applicant
INVENTIVE RESOURCES, INC.
200 GREGORY LN.
SUITE C-100
PLEASANT HILL,  CA  94523 -3389
Applicant Contact DAVID W SCHLERF
Correspondent
INVENTIVE RESOURCES, INC.
200 GREGORY LN.
SUITE C-100
PLEASANT HILL,  CA  94523 -3389
Correspondent Contact DAVID W SCHLERF
Classification Product Code
MQC  
Date Received12/11/2001
Decision Date 02/22/2002
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-