FDA 510(k) Application Details - K022408

Device Classification Name Powder, Porcelain

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510(K) Number K022408
Device Name Powder, Porcelain
Applicant B.B.'S PROPHY SHOP
GRUNSTR.2
GREVENBROICH D-41516 DE
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Contact HORST MICHAEL BIRKHOFF
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Regulation Number 872.6660

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Classification Product Code EIH
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Date Received 07/24/2002
Decision Date 09/06/2002
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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