FDA 510(k) Application Details - K040874

Device Classification Name Aligner, Sequential

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510(K) Number K040874
Device Name Aligner, Sequential
Applicant ALLESEE ORTHODONTIC APPLIANCES
1717 WEST COLLINS AVENUE
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 NXC
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Date Received 04/02/2004
Decision Date 06/18/2004
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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