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K Number
K960630
Device Name
ANSPAHC SPEED REDUCER
Manufacturer
THE ANSPACH EFFORT, INC.
Date Cleared
1996-11-19

(284 days)

Product Code
HBB
Regulation Number
882.4370
Type
Traditional
Panel
NE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

§ 882.4370 Pneumatic cranial drill motor.

(a)
Identification. A pneumatic cranial drill motor is a pneumatically operated power source used with removable rotating surgical cutting tools or drill bits on a patient's skull.(b)
Classification. Class II (performance standards).