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 Methyl Methacrylate For Cranioplasty
510(k) Number K071791
Device Name MODIFICATION TO CRANIOPLASTIC, MODEL 43-1280
Applicant
Codman & Shurtleff, Inc.
325 Paramount Dr.
Raynham,  MA  02767 -0350
Applicant Contact RACHEL CREANE
Correspondent
Codman & Shurtleff, Inc.
325 Paramount Dr.
Raynham,  MA  02767 -0350
Correspondent Contact RACHEL CREANE
Regulation Number882.5300
Classification Product Code
GXP  
Date Received07/02/2007
Decision Date 07/30/2007
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
-
-