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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 K031851
Device Name DENTISEPTIC HPC
Applicant
Bethel, Inc.
320 S. Vine Ave.
Tyler,  TX  75702
Applicant Contact ERIC WADE
Correspondent
Bethel, Inc.
320 S. Vine Ave.
Tyler,  TX  75702
Correspondent Contact ERIC WADE
Regulation Number872.4200
Classification Product Code
EFB  
Date Received06/16/2003
Decision Date 08/01/2003
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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