FDA 510(k) Application Details - K120852

Device Classification Name Powder, Porcelain

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510(K) Number K120852
Device Name Powder, Porcelain
Applicant KEROX LTD
55 Northern Blvd
Suite 200
Great Neck, NY 11021 US
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Contact SANGRAM YADAV
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Regulation Number 872.6660

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Classification Product Code EIH
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Date Received 03/21/2012
Decision Date 06/06/2012
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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