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FDA 510(k) Application Details - K014060
Device Classification Name
Drills, Burrs, Trephines & Accessories (Simple, Powered)
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510(K) Number
K014060
Device Name
Drills, Burrs, Trephines & Accessories (Simple, Powered)
Applicant
MICROAIRE SURGICAL INSTRUMENTS, INC.
1641 EDLICH DR.
CHARLOTTESVILLE, VA 22911 US
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CARL ANGLES
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Regulation Number
882.4310
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Classification Product Code
HBE
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More FDA Info for this Product Code
Date Received
12/10/2001
Decision Date
03/05/2002
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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