FDA 510(k) Application Details - K082556

Device Classification Name Aligner, Sequential

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510(K) Number K082556
Device Name Aligner, Sequential
Applicant CLEARCORRECT, INC.
220 RIVER ROAD
CLAREMONT, NH 03743 US
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Contact WILLIAM GREENROSE
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Regulation Number 872.5470

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Classification Product Code NXC
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Date Received 09/04/2008
Decision Date 02/06/2009
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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