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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 K991893
Device Name PARALLAX TRACER RADIOPAQUE PARTICLES
Applicant
PARALLAX MEDICAL, INC.
453 RAVENDALE DR., SUITE B
MOUNTAIN VIEW,  CA  94043
Applicant Contact SUSAN G MARQUES
Correspondent
PARALLAX MEDICAL, INC.
453 RAVENDALE DR., SUITE B
MOUNTAIN VIEW,  CA  94043
Correspondent Contact SUSAN G MARQUES
Regulation Number882.5300
Classification Product Code
MYU  
Date Received06/03/1999
Decision Date 08/13/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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