LIMITORR VOLUME LIMITING EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM, MODELS INS9020, INS9030


Device Classification Name

shunt, central nervous system and components

510(k) Number K072929
Device Name LIMITORR VOLUME LIMITING EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM, MODELS INS9020, INS9030
Applicant
INTEGRA LIFESCIENCES CORPORATION
311 enterprise dr.
plainsboro, 
NJ 
08536

Applicant Contact darlene m welsh
Correspondent
INTEGRA LIFESCIENCES CORPORATION
311 enterprise dr.
plainsboro, 
NJ 
08536

Correspodent Contact darlene m welsh
Regulation Number 882.5550
Classification Product Code
JXG  
Date Received 10/16/2007
Decision Date 12/07/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No