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 K102739
Device Name HYDROCOLOR 5
Applicant
Cascades Device Consulting Associates
19379 Blue Lake Loop
Bend,  OR  97702 -1923
Applicant Contact GERALD W SHIPPS
Correspondent
Cascades Device Consulting Associates
19379 Blue Lake Loop
Bend,  OR  97702 -1923
Correspondent Contact GERALD W SHIPPS
Regulation Number872.3660
Classification Product Code
ELW  
Date Received09/22/2010
Decision Date 12/08/2010
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
-
-