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510(k) Data Aggregation
K Number
K041978Device Name
REPROCESSED DIAMOND BURS
Manufacturer
Date Cleared
2004-11-23
(123 days)
Product Code
Regulation Number
882.4310Why did this record match?
Product Code :
NLN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Reprocessed Diamond Burs are indicated for use in patients requiring surgery involving bone and bony structures.
Device Description
Diamond Burs are specially designed surgical accessories designed to help the surgeon cut and drill bone and bony structures during orthopedic procedures.
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