FDA 510(k) Application Details - K091964

Device Classification Name Floss, Dental

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510(K) Number K091964
Device Name Floss, Dental
Applicant PROCTER & GAMBLE CO.
8700 MASON-MONTGOMERY RD.
MASON, OH 45040 US
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Contact VICTORIA P SCHOFIELD
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Regulation Number 872.6390

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Classification Product Code JES
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Date Received 07/01/2009
Decision Date 09/24/2009
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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