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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 K811154
Device Name HOYT ECONO-TRAY
Applicant
HOYT LABORATORIES
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
HOYT LABORATORIES
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number872.6870
Classification Product Code
KMT  
Date Received04/28/1981
Decision Date 05/13/1981
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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