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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cleaner, Denture, Mechanical
510(k) Number K852906
Device Name DURACLEAN DENTURE CLEANER
Applicant
Astron Dental Corp.
280 Holdbrook Dr.
Wheeling,  IL  60090
Applicant Contact ROBERT E MULLER
Correspondent
Astron Dental Corp.
280 Holdbrook Dr.
Wheeling,  IL  60090
Correspondent Contact ROBERT E MULLER
Regulation Number872.3530
Classification Product Code
JER  
Date Received07/09/1985
Decision Date 07/31/1985
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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