ACCURA ELITE SHUNT SYSTEM


Device Classification Name

shunt, central nervous system and components

510(k) Number K024040
Device Name ACCURA ELITE SHUNT SYSTEM
Original Applicant
PHOENIX BIOMEDICAL CORP.
2495 general armistead ave.
p.o. box 80390
norristown, 
PA 
19403

Original Contact courtney smith
Regulation Number 882.5550
Classification Product Code
JXG  
Date Received 12/06/2002
Decision Date 01/27/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No