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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 K925678
Device Name ATHENA HIGH SPEED HANDPIECE
Applicant
Athena Technology, Inc.
420 S. Vermont Ave.
Glendora,  CA  91740
Applicant Contact WILLIAM T ANDERSON
Correspondent
Athena Technology, Inc.
420 S. Vermont Ave.
Glendora,  CA  91740
Correspondent Contact WILLIAM T ANDERSON
Regulation Number872.4200
Classification Product Code
EFB  
Date Received11/10/1992
Decision Date 12/15/1994
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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