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 K152481
Device Name DURAFORM Dural Graft Implant
Applicant
CODMAN & SHURTLEFF, INC.
325 PARAMOUNT DRIVE
RAYNHAM,  MA  02767
Applicant Contact JENNIFER SIU
Correspondent
CODMAN & SHURTLEFF, INC.
325 PARAMOUNT DRIVE
RAYNHAM,  MA  02767
Correspondent Contact JENNIFER SIU
Regulation Number882.5910
Classification Product Code
GXQ  
Date Received08/31/2015
Decision Date 10/30/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
-
-