QUICKSET MIMIX BONE VOID FILLER


Device Classification Name

methyl methacrylate for cranioplasty

510(k) Number K023718
Device Name QUICKSET MIMIX BONE VOID FILLER
Original Applicant
WALTER LORENZ SURGICAL, INC.
56 east bell dr.
p.o. box 587
warsaw, 
IN 
46581

Original Contact kacy arnold
Regulation Number 882.5300
Classification Product Code
GXP  
Date Received 11/05/2002
Decision Date 12/04/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No