FDA 510(k) Application Details - K972889

Device Classification Name Controller, Foot, Handpiece And Cord

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510(K) Number K972889
Device Name Controller, Foot, Handpiece And Cord
Applicant W & H DENTALWERK
IGNAZ-GLASER-STRASSE 53
BURMOOS AT
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Contact HERBERT TRASCHWANDTNER
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Regulation Number 872.4200

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Classification Product Code EBW
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Date Received 08/05/1997
Decision Date 01/22/1998
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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