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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Handpiece, Air-Powered, Dental
510(k) Number K010127
Device Name W & H ASSISTINA
Applicant
A-DEC, INC.
2601 CRESTVIEW DR.
NEWBERG,  OR  97132 -9257
Applicant Contact LOVENA STANDRIDGE
Correspondent
A-DEC, INC.
2601 CRESTVIEW DR.
NEWBERG,  OR  97132 -9257
Correspondent Contact LOVENA STANDRIDGE
Regulation Number872.4200
Classification Product Code
EFB  
Date Received01/03/2001
Decision Date 10/05/2001
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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