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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Chair, Dental, With Operative Unit
510(k) Number K151987
Device Name DCI Edge Dental Chair with Operative Unit
Applicant
Dci
305 N. Springbrook Rd.
Newberg,  OR  97132
Applicant Contact ROBERT BELLINGHAM
Correspondent
Dci
305 N. Springbrook Rd.
Newberg,  OR  97132
Correspondent Contact ROBERT BELLINGHAM
Regulation Number872.6250
Classification Product Code
KLC  
Subsequent Product Code
EIA  
Date Received07/17/2015
Decision Date 06/01/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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