HERMETIC PLUS EXTERNAL CSF DRAINAGE SYSTEMS, INS-8301,INS-8302,INS-8700, NL850-830N


Device Classification Name

shunt, central nervous system and components

510(k) Number K030289
Device Name HERMETIC PLUS EXTERNAL CSF DRAINAGE SYSTEMS, INS-8301,INS-8302,INS-8700, NL850-830N
Original Applicant
INTEGRA LIFESCIENCES CORP.
311 enterprise dr.
plainsboro, 
NJ 
08536

Original Contact donna wallace
Regulation Number 882.5550
Classification Product Code
JXG  
Date Received 01/28/2003
Decision Date 02/26/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No