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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 K850103
Device Name GDC-1489 A CASTING ALLOY
Applicant
Deringer-Ney, Inc.
Ney Industrial Park
Bloomfield,  CT  06002
Applicant Contact DONALD V LANDMAN
Correspondent
Deringer-Ney, Inc.
Ney Industrial Park
Bloomfield,  CT  06002
Correspondent Contact DONALD V LANDMAN
Regulation Number872.3060
Classification Product Code
EJS  
Date Received01/11/1985
Decision Date 02/08/1985
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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