FDA 510(k) Application Details - K030172

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

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510(K) Number K030172
Device Name Drills, Burrs, Trephines & Accessories (Simple, Powered)
Applicant BRASSELER USA I, L.P.
4837 MCGRATH ST., SUITE J
VENTURA, CA 93003 US
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Contact ANTHONY V ROSE
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Regulation Number 882.4310

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Classification Product Code HBE
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Date Received 01/17/2003
Decision Date 04/03/2003
Decision SESE - SUBST EQUIV
Classification Advisory Committee NE - Neurology
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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