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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 K024359
Device Name VISTA SCIENTIFIC BARIUM SULFATE, MODEL 3001-1
Applicant
VISTA SCIENTIFIC, LLC
7960 NIWOT RD.
UNIT B-7
NIWOT,  CO  80503
Applicant Contact JONATHAN MODINE
Correspondent
VISTA SCIENTIFIC, LLC
7960 NIWOT RD.
UNIT B-7
NIWOT,  CO  80503
Correspondent Contact JONATHAN MODINE
Regulation Number882.5300
Classification Product Code
MYU  
Date Received12/30/2002
Decision Date 08/08/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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