FDA 510(k) Application Details - K974761

Device Classification Name Toothbrush, Manual

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510(K) Number K974761
Device Name Toothbrush, Manual
Applicant JOHN O. BUTLER CO.
333 WEST WACKER DR.
CHICAGO, IL 60606 US
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Contact THOMAS J MULDOON
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Regulation Number 872.6855

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Classification Product Code EFW
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Date Received 12/19/1997
Decision Date 06/16/1998
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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