CONCERT CRANIOPLAST


Device Classification Name

methyl methacrylate for cranioplasty

510(k) Number K023575
Device Name CONCERT CRANIOPLAST
Original Applicant
IMMEDICA, INC.
719 a street, ne
washington, 
DC 
20002

Original Contact russell pagano
Regulation Number 882.5300
Classification Product Code
GXP  
Date Received 10/24/2002
Decision Date 01/22/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No