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 Dura Substitute
510(k) Number K061487
Device Name DURAMATRIX COLLAGEN DURA SUBSTITUTE MEMBRANE - ONLAY AND SUTURABLE
Applicant
COLLAGEN MATRIX, INC.
509 COMMERCE ST.
FRANKLIN LAKES,,  NJ  07417
Applicant Contact PEGGY HANSEN
Correspondent
COLLAGEN MATRIX, INC.
509 COMMERCE ST.
FRANKLIN LAKES,,  NJ  07417
Correspondent Contact PEGGY HANSEN
Regulation Number882.5910
Classification Product Code
GXQ  
Date Received05/31/2006
Decision Date 06/26/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
-
-