FDA 510(k) Application Details - K973776

Device Classification Name Bracket, Plastic, Orthodontic

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510(K) Number K973776
Device Name Bracket, Plastic, Orthodontic
Applicant CDB CORP.
9201 INDUSTRIAL BLVD.
LELAND, NC 28451 US
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Contact SYLVIA C JOYCE
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Regulation Number 872.5470

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Classification Product Code DYW
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Date Received 10/03/1997
Decision Date 11/21/1997
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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