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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tray, Fluoride, Disposable
510(k) Number K871784
Device Name TOP FORM II TRAYS, DISPOS FOAM-LINED TOP GEL APPLI
Applicant
Colgate-Hoyt Laboratories
One Colgate Way
Canton,  MA  02021
Applicant Contact JOHN J VOZELLA
Correspondent
Colgate-Hoyt Laboratories
One Colgate Way
Canton,  MA  02021
Correspondent Contact JOHN J VOZELLA
Regulation Number872.6870
Classification Product Code
KMT  
Date Received05/06/1987
Decision Date 05/27/1987
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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