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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name accessory, barium sulfate, methyl methacrylate for cranioplasty
510(k) Number K023445
Device Name TRACERS BONE CEMENT OPACIFIER
Applicant
PARALLAX MEDICAL, INC.
940 DISC DR.
SCOTTS VALLEY,  CA  95066 -4544
Applicant Contact LINDA BRADLEY
Correspondent
PARALLAX MEDICAL, INC.
940 DISC DR.
SCOTTS VALLEY,  CA  95066 -4544
Correspondent Contact LINDA BRADLEY
Regulation Number882.5300
Classification Product Code
MYU  
Date Received10/15/2002
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
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