FDA 510(k) Application Details - K012453

Device Classification Name Motor, Drill, Electric

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510(K) Number K012453
Device Name Motor, Drill, Electric
Applicant SODEM SYSTEMS
110 CH. DU PONT DU CENTENAIRE
GENEVA CH-1228 CH
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Contact CAROLE BURNIER
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Regulation Number 882.4360

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Classification Product Code HBC
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Date Received 08/01/2001
Decision Date 10/22/2001
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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