FDA 510(k) Application Details - K963205

Device Classification Name Material, Impression

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510(K) Number K963205
Device Name Material, Impression
Applicant AMERICAN TOOTH INDUSTRIES
1819 SO. MAY ST.
2F
CHICAGO, IL 60608 US
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Contact ROBERT W BAUER
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Regulation Number 872.3660

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Classification Product Code ELW
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Date Received 08/09/1996
Decision Date 10/29/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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