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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 K875344
Device Name HERAEUS' HERAGAM 48, NON GAMMA 2 DEN. AMAL. ALLOY
Applicant
Kulzer, Inc.
111 N. Wabash Ave.
Chicago,  IL  60602
Applicant Contact BAUER, PHD
Correspondent
Kulzer, Inc.
111 N. Wabash Ave.
Chicago,  IL  60602
Correspondent Contact BAUER, PHD
Regulation Number872.3070
Classification Product Code
EJJ  
Date Received12/30/1987
Decision Date 03/18/1988
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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