FDA 510(k) Application Details - K014068

Device Classification Name Controller, Foot, Handpiece And Cord

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510(K) Number K014068
Device Name Controller, Foot, Handpiece And Cord
Applicant W & H DENTALWERK BUERMOOS GMBH
53 IGNAZ-GLAZER-STRASSE
BUERMOOS 5111 AT
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Contact RALF BENDA
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Regulation Number 872.4200

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Classification Product Code EBW
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Date Received 12/10/2001
Decision Date 05/03/2002
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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