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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tray, Impression, Preformed
510(k) Number K841323
Device Name FUZZY TRAY
Applicant
Buffalo Dental Mfg. Co., Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Buffalo Dental Mfg. Co., Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number872.6880
Classification Product Code
EHY  
Date Received04/02/1984
Decision Date 06/27/1984
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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