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 K093266
Device Name MAM COOLER
Applicant
Mam International AG
Corporate Park Dr. 106
White Plains,  NY  10604
Applicant Contact MICHAEL TEDESCO
Correspondent
Mam International AG
Corporate Park Dr. 106
White Plains,  NY  10604
Correspondent Contact MICHAEL TEDESCO
Regulation Number872.5550
Classification Product Code
KKO  
Date Received10/19/2009
Decision Date 07/27/2010
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
-
-