FDA 510(k) Application Details - K011061

Device Classification Name Handpiece, Contra- And Right-Angle Attachment, Dental

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510(K) Number K011061
Device Name Handpiece, Contra- And Right-Angle Attachment, Dental
Applicant W & H DENTALWERK BUERMOOS GMBH
53 IGNAZ-GLAZER-STRASSE
BUERMOOS 5111 AT
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Contact HERBERT TRASCHWANDTNER
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Regulation Number 872.4200

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Classification Product Code EGS
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Date Received 04/06/2001
Decision Date 06/28/2001
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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