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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Agent, Polishing, Abrasive, Oral Cavity
510(k) Number K904199
Device Name HORIZON REGULAR ETCHING GEL
Applicant
Horizon Chemical Co.
3666 Eleen Davis Co.
Memphis,  TN  38133
Applicant Contact JEFF I WILLIAMS
Correspondent
Horizon Chemical Co.
3666 Eleen Davis Co.
Memphis,  TN  38133
Correspondent Contact JEFF I WILLIAMS
Regulation Number872.6030
Classification Product Code
EJR  
Date Received09/12/1990
Decision Date 12/05/1990
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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