FDA 510(k) Application Details - K090937

Device Classification Name Controller, Foot, Handpiece And Cord

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510(K) Number K090937
Device Name Controller, Foot, Handpiece And Cord
Applicant SCICAN LTD.
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 EBW
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Date Received 04/03/2009
Decision Date 07/24/2009
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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