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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Alloy, Metal, Base
510(k) Number K851515
Device Name HERAENIUM CA
Applicant
Heraeus Dental Gold Corp.
222-34 96th. Ave.
Queens Village,  NY  11429
Applicant Contact FRANK H GROSSMAN
Correspondent
Heraeus Dental Gold Corp.
222-34 96th. Ave.
Queens Village,  NY  11429
Correspondent Contact FRANK H GROSSMAN
Regulation Number872.3710
Classification Product Code
EJH  
Date Received04/15/1985
Decision Date 09/23/1985
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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