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 Material, Impression
510(k) Number K032116
Device Name TULIP COLORSWITCH
Applicant
Cavex Holland BV
P.O. Box 852
Haarlem,  NL 2003 RW
Applicant Contact RICHARD WOORTMAN
Correspondent
Cavex Holland BV
P.O. Box 852
Haarlem,  NL 2003 RW
Correspondent Contact RICHARD WOORTMAN
Regulation Number872.3660
Classification Product Code
ELW  
Date Received07/09/2003
Decision Date 09/30/2003
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
-
-