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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 K913535
Device Name A-DEC DECADE 1020 CHAIR
Applicant
A-DEC, INC.
2601 CRESTVIEW DR.
NEWBERG,  OR  97132 -9257
Applicant Contact KURT NICHOLS
Correspondent
A-DEC, INC.
2601 CRESTVIEW DR.
NEWBERG,  OR  97132 -9257
Correspondent Contact KURT NICHOLS
Regulation Number872.6250
Classification Product Code
KLC  
Date Received08/09/1991
Decision Date 10/09/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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