FDA 510(k) Application Details - K003090

Device Classification Name Unit, Operative Dental

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510(K) Number K003090
Device Name Unit, Operative Dental
Applicant MIDMARK CORP.
OUTE 47 WEST, VISTA DR.
VERSAILLES, OH 45380 US
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Contact MIKE SNYDER
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Regulation Number 872.6640

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Classification Product Code EIA
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Date Received 10/03/2000
Decision Date 10/18/2000
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Statement
Type Abbreviated
Reviewed By Third Party Y
Expedited Review



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