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510(k) Data Aggregation
K Number
K062979Device Name
THYROSAMPLER
Manufacturer
Date Cleared
2007-05-30
(243 days)
Product Code
Regulation Number
876.1075Why did this record match?
Applicant Name (Manufacturer) :
ACD MEDICAL INNOVATION CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Thyrosampler® Kurtaran Frass is indicated for ultrasound guided fine needle aspiration of soft thyroid nodules that are about 1 cm or greater in diameter, located up to depth of 4 cm from the skin.
Device Description
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