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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Positioner, Tooth, Preformed
510(k) Number K821458
Device Name DYNAMIC FUNTIONAL POSITIONER
Applicant
DYNAMIC FUNCTIONAL POSITIONER, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
DYNAMIC FUNCTIONAL POSITIONER, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number872.5525
Classification Product Code
KMY  
Date Received05/07/1982
Decision Date 06/09/1982
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
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