FDA 510(k) Application Details - K020394

Device Classification Name Adhesive, Bracket And Tooth Conditioner, Resin

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510(K) Number K020394
Device Name Adhesive, Bracket And Tooth Conditioner, Resin
Applicant 3M UNITEK
2724 SOUTH PECK RD.
MONROVIA, CA 91016 US
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Contact MARLYN SCHEFF
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Regulation Number 872.3750

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Classification Product Code DYH
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Date Received 02/06/2002
Decision Date 04/12/2002
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

FDA Source Information for K020394


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