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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 K944575
Device Name AQUAFRESH PLAQUE FIGHTING GUM
Applicant
Smithkline Beecham Consumer Healthcare Products
1500 Littleton Rd.
Parsippany,  NJ  07054
Applicant Contact ANTHONY G AMITRANO
Correspondent
Smithkline Beecham Consumer Healthcare Products
1500 Littleton Rd.
Parsippany,  NJ  07054
Correspondent Contact ANTHONY G AMITRANO
Regulation Number872.6030
Classification Product Code
EJR  
Date Received09/19/1994
Decision Date 12/15/1994
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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