FDA 510(k) Application Details - K023232

Device Classification Name Unit, Oral Irrigation

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510(K) Number K023232
Device Name Unit, Oral Irrigation
Applicant SMART PRACTICE
3400 EAST MCDOWELL RD.
PHOENIX, AZ 85008 US
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Contact KIM SULLIVAN
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Regulation Number 872.6510

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Classification Product Code EFS
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Date Received 09/27/2002
Decision Date 12/11/2002
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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