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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Alloy, Gold-Based Noble Metal
510(k) Number K990670
Device Name HELIOFORM GOLD-BASED ALLOY
Applicant
C. Hafner GmbH & Co.
Three First National Plaza
70 W. Madison St. Suite 3300
Chicago,  IL  60602 -4207
Applicant Contact JOHN F LEMKER
Correspondent
C. Hafner GmbH & Co.
Three First National Plaza
70 W. Madison St. Suite 3300
Chicago,  IL  60602 -4207
Correspondent Contact JOHN F LEMKER
Regulation Number872.3060
Classification Product Code
EJT  
Date Received03/02/1999
Decision Date 04/02/1999
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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