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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Controller, Foot, Handpiece And Cord
510(k) Number K032572
Device Name A-DEC/W&H ELECTRIC MOTOR, MODEL EA-50LT
Applicant
A-Dec, Inc.
2601 Crestview Dr.
Newberg,  OR  97132 -9257
Applicant Contact TOM LOUISELL
Correspondent
A-Dec, Inc.
2601 Crestview Dr.
Newberg,  OR  97132 -9257
Correspondent Contact TOM LOUISELL
Regulation Number872.4200
Classification Product Code
EBW  
Date Received08/20/2003
Decision Date 12/03/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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