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510(k) Data Aggregation
K Number
K990515Device Name
MATHIS VERTEBRAL AND BONE BIOPSY SYSTEM
Manufacturer
INTERNATIONAL MEDICAL SYSTEMS
Date Cleared
1999-05-13
(84 days)
Product Code
KNW
Regulation Number
876.1075Why did this record match?
Applicant Name (Manufacturer) :
INTERNATIONAL MEDICAL SYSTEMS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Mathis Vertebral and Bone Biopsy Systems are intended for use by physicians performing bone marrow biopsy procedures.
Device Description
The Mathis Vertebral and Bone Biopsy System is a standard bone marrow biopsy needle consisting of a cannula with a sharpened distal end and a stylet received coaxially in the cannula and having a sharpened distal end protruding from the distal end of the cannula. The cannula is insert molded to a hub with standard threadable lug tabs. The stylet is insert molded to a standard hub. When the stylet assembly is placed into the cannula assembly, the entire cannula/stylet unit can be threaded into a removable gripable handle.
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