FDA 510(k) Application Details - K062344

Device Classification Name Sealant, Pit And Fissure, And Conditioner

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510(K) Number K062344
Device Name Sealant, Pit And Fissure, And Conditioner
Applicant VOCO GMBH
ANTON-FLETTNER-STRASSE 1-3
CUXHAVEN D-27472 DE
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Contact MICHAEL SUES
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Regulation Number 872.3765

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Classification Product Code EBC
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Date Received 08/11/2006
Decision Date 10/02/2006
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Statement
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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