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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Alloy, Amalgam
510(k) Number K902248
Device Name LUXALLOY CAPS (PREDOSED CAPSULES)
Applicant
Degussa AG
Postfach 110533
D-6000 Frankfurt 11
West Germany,  DE
Applicant Contact MACKERT
Correspondent
Degussa AG
Postfach 110533
D-6000 Frankfurt 11
West Germany,  DE
Correspondent Contact MACKERT
Regulation Number872.3070
Classification Product Code
EJJ  
Date Received05/18/1990
Decision Date 07/13/1990
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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