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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Toothbrush, Manual
510(k) Number K021383
Device Name ZEODYNE TOOTHBRUSH WITH AGION ANTIMICROBIAL
Applicant
Agion Technologies, LLC
60 Audubon Rd.
Wakefield,  MA  01880
Applicant Contact PAUL C FORD
Correspondent
Agion Technologies, LLC
60 Audubon Rd.
Wakefield,  MA  01880
Correspondent Contact PAUL C FORD
Regulation Number872.6855
Classification Product Code
EFW  
Date Received05/02/2002
Decision Date 07/17/2002
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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