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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 K853882
Device Name SUPER SLICK
Applicant
Tang Products
P.O. Box 440972
Aurora,  CO  80044
Applicant Contact JOHN HALFEN
Correspondent
Tang Products
P.O. Box 440972
Aurora,  CO  80044
Correspondent Contact JOHN HALFEN
Regulation Number872.6870
Classification Product Code
KMT  
Date Received09/19/1985
Decision Date 11/18/1985
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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