FDA 510(k) Application Details - K012744

Device Classification Name Unit, Operative Dental

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510(K) Number K012744
Device Name Unit, Operative Dental
Applicant MHT OPTIC RESEARCH AG
MANDACHSTR. 50
NIEDERHASLI CH-8155 CH
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Contact MARKUS ANGST
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Regulation Number 872.6640

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Classification Product Code EIA
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Date Received 08/16/2001
Decision Date 01/23/2002
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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