FDA 510(k) Application Details - K040076

Device Classification Name Drills, Burrs, Trephines & Accessories (Simple, Powered)

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510(K) Number K040076
Device Name Drills, Burrs, Trephines & Accessories (Simple, Powered)
Applicant THE ANSPACH EFFORT, INC.
4500 RIVERSIDE DR.
PALM BEACH GARDENS, FL 33410 US
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Contact WILLIAM G CONETY
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Regulation Number 882.4310

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Classification Product Code HBE
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Date Received 01/14/2004
Decision Date 03/15/2004
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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