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510(k) Data Aggregation
K Number
K971342Device Name
DISK WHISK CUTTING DEVICE (CONICAL, ELLIPTICAL AND BALL HEAD)
Manufacturer
DISK WHISK, INC.
Date Cleared
1997-07-08
(89 days)
Product Code
HWE
Regulation Number
878.4820Why did this record match?
Applicant Name (Manufacturer) :
DISK WHISK, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The product is indicated for use in endoscopic and nonendoscopic orthopedic procedures, to assist in the removal of fibrous disk material in the spine and for the decortication of bone.
Device Description
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