FDA 510(k) Application Details - K040416

Device Classification Name Toothbrush, Powered

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510(K) Number K040416
Device Name Toothbrush, Powered
Applicant PHILIPS ORAL HEALTHCARE, INC.
35301 S.E. CENTER ST.
SNOQUALMIE, WA 98065 US
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Contact ROSE DEGIACOMO
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Regulation Number 872.6865

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Classification Product Code JEQ
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Date Received 02/18/2004
Decision Date 07/02/2004
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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