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510(k) Data Aggregation
K Number
K024359Device Name
VISTA SCIENTIFIC BARIUM SULFATE, MODEL 3001-1
Manufacturer
VISTA SCIENTIFIC, LLC
Date Cleared
2003-08-08
(221 days)
Product Code
MYU
Regulation Number
882.5300Why did this record match?
Applicant Name (Manufacturer) :
VISTA SCIENTIFIC, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Vista Scientific Barium Sulfate™ is intended for use as an additive to Codman Cranioplastic™ (Type 1-Slow set) to provide radiopacity for imaging purposes.
Device Description
Vista Scientific Barium Sulfate is a dry powder supplied sterile and non-pyrogenic for use as a radiopacifying additive to Codman Cranioplastic™ (Type 1-Slow set) bone cement. The Barium Sulfate is supplied in a quantity of 6 grams, packaged in a closed 120 mL polymer container, and sealed within a double sterile peel pouch package configuration.
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