TRACERS BONE CEMENT OPACIFIER


Device Classification Name

accessory,barium sulfate,methyl methacrylate for cranioplasty

510(k) Number K023445
Device Name TRACERS BONE CEMENT OPACIFIER
Original Applicant
PARALLAX MEDICAL, INC.
940 disc dr.
scotts valley, 
CA 
95066 -4544

Original Contact linda bradley
Regulation Number 882.5300
Classification Product Code
MYU  
Date Received 10/15/2002
Decision Date 03/11/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No