FDA 510(k) Application Details - K041978

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

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510(K) Number K041978
Device Name Drills, Burrs, Trephines And Accessories (Simple Powered), Reprocessed
Applicant ALLIANCE MEDICAL CORP.
10232 SOUTH 51ST ST.
PHOENIX, AZ 85044 US
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Contact ERIC VARTY
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Regulation Number 882.4310

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Classification Product Code NLN
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Date Received 07/23/2004
Decision Date 11/23/2004
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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