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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
Predetermined Change
Control Plan Authorized		 No
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