FDA 510(k) Application Details - K073678

Device Classification Name Drill, Bone, Powered

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510(K) Number K073678
Device Name Drill, Bone, Powered
Applicant NAKANISHI, INC.
1425 K STREET, N.W.
SUITE 1100
WASHINGTON, DC 20005 US
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Contact KEITH BARRITT
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Regulation Number 872.4120

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Classification Product Code DZI
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Date Received 12/28/2007
Decision Date 07/10/2008
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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