FDA 510(k) Application Details - K032572

Device Classification Name Controller, Foot, Handpiece And Cord

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510(K) Number K032572
Device Name Controller, Foot, Handpiece And Cord
Applicant A-DEC, INC.
2601 CRESTVIEW DR.
NEWBERG, OR 97132-9257 US
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Contact TOM LOUISELL
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Regulation Number 872.4200

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Classification Product Code EBW
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Date Received 08/20/2003
Decision Date 12/03/2003
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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