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 Cord, Retraction
510(k) Number K091380
Device Name CORDCAP
Applicant
Centrix, Inc.
770 River Rd.
Shelton,  CT  06484
Applicant Contact JOHN DISCKO
Correspondent
Centrix, Inc.
770 River Rd.
Shelton,  CT  06484
Correspondent Contact JOHN DISCKO
Classification Product Code
MVL  
Date Received05/11/2009
Decision Date 07/30/2009
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
-
-