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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 K925324
Device Name A-DEC 2184 DUO UNIT
Applicant
A-DEC, INC.
2601 CRESTVIEW DR.
NEWBERG,  OR  97132 -9257
Applicant Contact PAT RIDENOUR
Correspondent
A-DEC, INC.
2601 CRESTVIEW DR.
NEWBERG,  OR  97132 -9257
Correspondent Contact PAT RIDENOUR
Regulation Number872.6250
Classification Product Code
KLC  
Date Received10/21/1992
Decision Date 12/09/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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