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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 K983081
Device Name BEGOPAL 300
Applicant
Bego Bremer Goldschlaegerei Wilh. Herbst GmbH & CO
Wilhelm-Herbst-Strasse 1
Bremen,  DE 28359
Correspondent
Bego Bremer Goldschlaegerei Wilh. Herbst GmbH & CO
Wilhelm-Herbst-Strasse 1
Bremen,  DE 28359
Regulation Number872.3060
Classification Product Code
EJS  
Date Received09/02/1998
Decision Date 10/28/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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