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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 K974671
Device Name ATHENA 20R S TYPE SLOW SPEED HANDPIECE MOTOR
Applicant
Athena Technology, Inc.
984 N. Amelia Ave.
San Dimas,  CA  91773
Applicant Contact WILLIAM T ANDERSON
Correspondent
Athena Technology, Inc.
984 N. Amelia Ave.
San Dimas,  CA  91773
Correspondent Contact WILLIAM T ANDERSON
Regulation Number872.4200
Classification Product Code
EFB  
Date Received12/15/1997
Decision Date 03/11/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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