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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Material, Impression
510(k) Number K980963
Device Name HONIGUM AUTOMIX IMPRESSION MATERIAL (FOIL BAGS) AND HONIGUM QUICK IMPRESSION MATERIAL (CARTRIDGES)
Applicant
Foremost Dental Mfg., Inc.
415 W. Aldine Ave. 10-A
Chicago,  IL  60657
Applicant Contact AN-SHIH CHENG
Correspondent
Foremost Dental Mfg., Inc.
415 W. Aldine Ave. 10-A
Chicago,  IL  60657
Correspondent Contact AN-SHIH CHENG
Regulation Number872.3660
Classification Product Code
ELW  
Date Received03/16/1998
Decision Date 05/11/1998
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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