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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 K093821
Device Name FS ALIGNER
Applicant
ALLESEE ORTHODONTIC APPLIANCES
1717 WEST COLLINS AVENUE
ORANGE,  CA  92867
Applicant Contact Wendy Garman
Correspondent
ALLESEE ORTHODONTIC APPLIANCES
1717 WEST COLLINS AVENUE
ORANGE,  CA  92867
Correspondent Contact Wendy Garman
Regulation Number872.5470
Classification Product Code
NXC  
Date Received12/14/2009
Decision Date 08/27/2010
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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