FDA 510(k) Application Details - K984508

Device Classification Name Drill, Dental, Intraoral

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510(K) Number K984508
Device Name Drill, Dental, Intraoral
Applicant W & H DENTALWERK BUERMOOS GMBH
53 IGNAZ-GLASER-STRASSE
A-5111
BUERMOOS 5111 AT
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Contact HERBERT TRASCHWANDTNER
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Regulation Number 872.4130

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Classification Product Code DZA
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Date Received 12/18/1998
Decision Date 06/25/1999
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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