FDA 510(k) Application Details - K042974

Device Classification Name Motor, Drill, Pneumatic

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510(K) Number K042974
Device Name Motor, Drill, Pneumatic
Applicant MEDICON, E.G.
GAENSAECKER 15
TUTTLINGEN D-78532 DE
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Contact JOACHIM SCHMID
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Regulation Number 882.4370

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Classification Product Code HBB
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Date Received 10/28/2004
Decision Date 01/13/2005
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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