AESCULAP- MEITHKE SHUNT SYSTEM


Device Classification Name

shunt, central nervous system and components

510(k) Number K110206
Device Name AESCULAP- MEITHKE SHUNT SYSTEM
Applicant
AESCULAP, INC.
3773 corporate parkway
center valley, 
PA 
18034

Applicant Contact kathy a racosky
Correspondent
AESCULAP, INC.
3773 corporate parkway
center valley, 
PA 
18034

Correspodent Contact kathy a racosky
Regulation Number 882.5550
Classification Product Code
JXG  
Date Received 01/25/2011
Decision Date 10/27/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls