FDA 510(k) Application Details - K073314

Device Classification Name Powder, Porcelain

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510(K) Number K073314
Device Name Powder, Porcelain
Applicant HEANY INDUSTRIES INC
249 BRIARWOOD LANE
SCOTTSVILLE, NY 14546 US
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Contact COREY DUNN
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Regulation Number 872.6660

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Classification Product Code EIH
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Date Received 11/26/2007
Decision Date 02/21/2008
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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