FDA 510(k) Application Details - K032408

Device Classification Name Bracket, Plastic, Orthodontic

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510(K) Number K032408
Device Name Bracket, Plastic, Orthodontic
Applicant SYBRON DENTAL SPECIALTIES, INC.
1717 W. COLLINS AVE.
ORANGE, CA 92867 US
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Contact COLLEEN BOSWELL
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Regulation Number 872.5470

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Classification Product Code DYW
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Date Received 08/04/2003
Decision Date 10/15/2003
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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