FDA 510(k) Application Details - K014188

Device Classification Name Airbrush

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510(K) Number K014188
Device Name Airbrush
Applicant DENTSPLY INTL.
570 WEST COLLEGE AVE.
YORK, PA 17405-0872 US
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Contact P. JEFFERY LEHN
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Regulation Number 872.6080

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Classification Product Code KOJ
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Date Received 12/21/2001
Decision Date 03/15/2002
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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