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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Amalgamator, Dental, Ac-Powered
510(k) Number K880993
Device Name AMALGAMATOR
Applicant
Acecodent, Inc.
41-80 Parsons Blvd.
Flushing,  NY  11355
Applicant Contact JAMES HWANG
Correspondent
Acecodent, Inc.
41-80 Parsons Blvd.
Flushing,  NY  11355
Correspondent Contact JAMES HWANG
Regulation Number872.3100
Classification Product Code
EFD  
Date Received03/08/1988
Decision Date 05/11/1988
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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