FDA 510(k) Application Details - K973876

Device Classification Name Handpiece, Air-Powered, Dental

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510(K) Number K973876
Device Name Handpiece, Air-Powered, Dental
Applicant KAVO AMERICA
ONE PRUDENTIAL PLAZA,
130 EAST RANDOLPH
CHICAGO, IL 60601 US
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Contact GREGORY W BOWMAN
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Regulation Number 872.4200

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Classification Product Code EFB
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Date Received 10/10/1997
Decision Date 12/19/1997
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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