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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Light, Operating, Dental
510(k) Number K893044
Device Name A-DEC DENTAL LIGHT
Applicant
A-Dec, Inc.
2601 Crestview Dr.
Newberg,  OR  97132
Applicant Contact JOHN LEWIS
Correspondent
A-Dec, Inc.
2601 Crestview Dr.
Newberg,  OR  97132
Correspondent Contact JOHN LEWIS
Regulation Number872.4630
Classification Product Code
EAZ  
Date Received04/24/1989
Decision Date 07/14/1989
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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