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 Device, Monitoring, Intracranial Pressure
510(k) Number K102875
Device Name CAMINO 110-4B OLM INTRACRANIAL PRESSURE MNITORING KIT; CAMINO 110-4G POST CRANIOTOMY SUBDURAL PRESSURE MONITORING KIT; C
Applicant
Integra LifeSciences Corporation
311 Enterprise Dr.
Planisboro,  NJ  08536
Applicant Contact DONNA MILLISKY
Correspondent
Integra LifeSciences Corporation
311 Enterprise Dr.
Planisboro,  NJ  08536
Correspondent Contact DONNA MILLISKY
Regulation Number882.1620
Classification Product Code
GWM  
Date Received10/01/2010
Decision Date 12/20/2010
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
Recalls CDRH Recalls
-
-