RUMBAR DRAINAGE SYSTEM


the company

Device Classification Name

shunt, central nervous system and components

510(k) Number K000514
Device Name RUMBAR DRAINAGE SYSTEM
Original Applicant
PHOENIX BIOMEDICAL CORP.
2495 general armstead ave.
p.o. box 80390
valley forge, 
PA 
19484

Original Contact courtney smith
Regulation Number 882.5550
Classification Product Code
JXG  
Date Received 02/16/2000
Decision Date 05/10/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

Type Traditional
Reviewed by Third Party No

Combination Product

No