FDA 510(k) Application Details - K102538

Device Classification Name Powder, Porcelain

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510(K) Number K102538
Device Name Powder, Porcelain
Applicant JYOTI CERAMIC INDUSTRIES PRIVATE LIMITED
C-21, NICE, SATPUR
NASHIK, MAHARASHTRA 422007 IN
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Contact RAJU MERANI
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Regulation Number 872.6660

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Classification Product Code EIH
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Date Received 09/03/2010
Decision Date 10/27/2010
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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