K Number
K011444Device Name
ANSPACH EMAX DRILL SYSTEM
Manufacturer
Date Cleared
2001-08-08
(89 days)
Product Code
Regulation Number
882.4360AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
More Information
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§ 882.4360 Electric cranial drill motor.
(a)
Identification. An electric cranial drill motor is an electrically operated power source used with removable rotating surgical cutting tools or drill bits on a patient's skull.(b)
Classification. Class II (performance standards).
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