PERF (OMMAYA STYLE) RESERVOIRS


Device Classification Name

shunt, central nervous system and components

510(k) Number K021644
Device Name PERF (OMMAYA STYLE) RESERVOIRS
Original Applicant
PHOENIX BIOMEDICAL CORP.
2495 general armistead ave.
p.o. box 80390
valley forge, 
PA 
19484

Original Contact courtney smith
Regulation Number 882.5550
Classification Product Code
JXG  
Date Received 05/20/2002
Decision Date 08/06/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No