FDA 510(k) Application Details - K953707

Device Classification Name Burnisher, Operative

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510(K) Number K953707
Device Name Burnisher, Operative
Applicant MEDTROL, INC.
2126 BERWICK
INVERNESS, IL 60067 US
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Contact BRUCE J SCHULLO
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Regulation Number 872.4565

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Classification Product Code EKJ
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Date Received 08/08/1995
Decision Date 01/04/1996
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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