FDA 510(k) Application Details - K052714

Device Classification Name Bracket, Plastic, Orthodontic

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510(K) Number K052714
Device Name Bracket, Plastic, Orthodontic
Applicant FDA AGENTS
17401 COMMERCE PARK BLVD.
TAMPA, FL 33647 US
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Contact STEVE KLAMIC
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Regulation Number 872.5470

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Classification Product Code DYW
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Date Received 09/29/2005
Decision Date 10/26/2005
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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