FDA 510(k) Application Details - K062418

Device Classification Name Handpiece, Air-Powered, Dental

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510(K) Number K062418
Device Name Handpiece, Air-Powered, Dental
Applicant SCICAN
1440 DON MILLS RD.
TORONTO, ONTARIO M3B 3P9 CA
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Contact BRENDA MURPHY
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Regulation Number 872.4200

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Classification Product Code EFB
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Date Received 08/18/2006
Decision Date 10/19/2006
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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