FDA 510(k) Application Details - K972857

Device Classification Name Motor, Drill, Electric

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510(K) Number K972857
Device Name Motor, Drill, Electric
Applicant MEDICON, E.G.
555 THIRTEENTH STREET, N.W.
WASHINGTON, DC 20004-1109 US
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Contact HOWARD M HOLSTEIN
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Regulation Number 882.4360

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Classification Product Code HBC
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Date Received 08/01/1997
Decision Date 01/16/1998
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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