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 Shunt, Central Nervous System And Components
510(k) Number K182265
Device Name CodMan Certas Plus Programmable Valve
Applicant
Integra Lifesciences Corp.
11 Cabot Blvd.
Mansfield,  MA  02048
Applicant Contact Nancy MacDonald
Correspondent
Integra Lifesciences Corp.
11 Cabot Blvd.
Mansfield,  MA  02048
Correspondent Contact Nancy MacDonald
Regulation Number882.5550
Classification Product Code
JXG  
Date Received08/21/2018
Decision Date 11/20/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-