FDA 510(k) Application Details - K022370

Device Classification Name Drills, Burrs, Trephines & Accessories (Manual)

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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
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Regulation Number 882.4300

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Classification Product Code HBG
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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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