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 Ring, Teething, Fluid-Filled
510(k) Number K053493
Device Name BERRY FRUITY TEETHER
Applicant
Evenflo Company, Inc.
707 Crossroads Ct.
Vandalia,  OH  45377
Applicant Contact RUBEN D COLMENARES
Correspondent
Evenflo Company, Inc.
707 Crossroads Ct.
Vandalia,  OH  45377
Correspondent Contact RUBEN D COLMENARES
Regulation Number872.5550
Classification Product Code
KKO  
Date Received12/15/2005
Decision Date 02/22/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-