FDA 510(k) Application Details - K040117

Device Classification Name Unit, Operative Dental

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510(K) Number K040117
Device Name Unit, Operative Dental
Applicant ARROW INDUSTRIES LLC
530 5TH STREET
NECHE, ND 58265-4033 US
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Contact ROBERT SYMINGTON
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Regulation Number 872.6640

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Classification Product Code EIA
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Date Received 01/20/2004
Decision Date 04/21/2004
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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