FDA 510(k) Application Details - K051342

Device Classification Name Cleanser, Denture, Over The Counter

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510(K) Number K051342
Device Name Cleanser, Denture, Over The Counter
Applicant BONYF AG
67 MAIN STREET
SILVER CREEK, NY 14136 US
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Contact DONNA MARIE HARTNETT
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Regulation Number 872.3520

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Classification Product Code EFT
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Date Received 05/23/2005
Decision Date 06/02/2006
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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