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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 K033230
Device Name TRACERS TA BONE CEMENT OPACIFIER, MODEL TCR-TA
Applicant
PARALLAX MEDICAL, INC.
940 DISC DR.
SCOTTS VALLEY,  CA  95066 -4544
Applicant Contact LINDA PAUL
Correspondent
PARALLAX MEDICAL, INC.
940 DISC DR.
SCOTTS VALLEY,  CA  95066 -4544
Correspondent Contact LINDA PAUL
Regulation Number882.5300
Classification Product Code
MYU  
Date Received10/06/2003
Decision Date 12/12/2003
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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