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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name aligner, sequential
510(k) Number K082556
Device Name CLEARCORRECT
Applicant
CLEARCORRECT, INC.
220 RIVER ROAD
CLAREMONT,  NH  03743
Applicant Contact WILLIAM GREENROSE
Correspondent
CLEARCORRECT, INC.
220 RIVER ROAD
CLAREMONT,  NH  03743
Correspondent Contact WILLIAM GREENROSE
Regulation Number872.5470
Classification Product Code
NXC  
Date Received09/04/2008
Decision Date 02/06/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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