FDA 510(k) Application Details - K042434

Device Classification Name Drill, Bone, Powered

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510(K) Number K042434
Device Name Drill, Bone, Powered
Applicant NOUVAG AG
REUSSWEHRSTRASSE 1
GEBENSTORF 5412 CH
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Contact ERICH FORSTER
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Regulation Number 872.4120

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Classification Product Code DZI
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Date Received 09/08/2004
Decision Date 11/03/2004
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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