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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 K854588
Device Name INSTA-GLAZE
Applicant
George Taub Products & Fusion Co., Inc.
277 New York Ave.
Jersey City,  NJ  07307
Applicant Contact LAWRENCE D TAUB
Correspondent
George Taub Products & Fusion Co., Inc.
277 New York Ave.
Jersey City,  NJ  07307
Correspondent Contact LAWRENCE D TAUB
Regulation Number872.6030
Classification Product Code
EJR  
Date Received11/18/1985
Decision Date 02/04/1986
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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