ACURA ELITE GRAVITY COMPENSATING RESERVOIR


Device Classification Name

shunt, central nervous system and components

510(k) Number K030468
Device Name ACURA ELITE GRAVITY COMPENSATING RESERVOIR
Applicant
PHOENIX BIOMEDICAL CORP.
2495 general armistead ave.
p.o. box 80390
valley forge, 
PA 
19484

Applicant Contact courtney smith
Correspondent
PHOENIX BIOMEDICAL CORP.
2495 general armistead ave.
p.o. box 80390
valley forge, 
PA 
19484

Correspodent Contact courtney smith
Regulation Number 882.5550
Classification Product Code
JXG  
Date Received 02/12/2003
Decision Date 10/15/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No