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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Alloy, Other Noble Metal
510(k) Number K851648
Device Name HERACOR SYSTEM HERACOR PLATINUM FOIL, BLENDGOLD NE
Applicant
Heraeus Dental Gold Corp.
111n. Wabash
Chicago,  IL  60602
Applicant Contact ROBERT N BAUER
Correspondent
Heraeus Dental Gold Corp.
111n. Wabash
Chicago,  IL  60602
Correspondent Contact ROBERT N BAUER
Regulation Number872.3060
Classification Product Code
EJS  
Date Received04/22/1985
Decision Date 06/04/1985
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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