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 K042558
Device Name EQUI-FLOW VALVE AND SHUNT SYSTEM
Applicant
Integra Neurosciences Implants S.A.
311 Enterprise Dr.
Planisboro,  NJ  08536
Applicant Contact JUDITH O'GRADY
Correspondent
Integra Neurosciences Implants S.A.
311 Enterprise Dr.
Planisboro,  NJ  08536
Correspondent Contact JUDITH O'GRADY
Regulation Number882.5550
Classification Product Code
JXG  
Date Received09/21/2004
Decision Date 10/06/2004
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
-
-