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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
Predetermined Change
Control Plan Authorized		 No
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