FDA 510(k) Application Details - K100731

Device Classification Name Handpiece, Air-Powered, Dental

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510(K) Number K100731
Device Name Handpiece, Air-Powered, Dental
Applicant HARRY J. BOSWORTH CO.
7227 NORTH HAMLIN AVE.
SKOKIE, IL 60076 US
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Contact GARY CHUVEN
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Regulation Number 872.4200

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Classification Product Code EFB
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Date Received 03/15/2010
Decision Date 12/03/2010
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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