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FDA 510(k) Application Details - K022370
Device Classification Name
Drills, Burrs, Trephines & Accessories (Manual)
More FDA Info for this Device
510(K) Number
K022370
Device Name
Drills, Burrs, Trephines & Accessories (Manual)
Applicant
MEDTRONIC XOMED, INC.
6743 SOUTHPOINT DR. NORTH
JACKSONVILLE, FL 32216 US
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Contact
B.L. MCDERMOTT
Other 510(k) Applications for this Contact
Regulation Number
882.4300
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Classification Product Code
HBG
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More FDA Info for this Product Code
Date Received
07/22/2002
Decision Date
10/18/2002
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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