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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Heat Source For Bleaching Teeth
510(k) Number K790378
Device Name REYNOLDS BLEACHING PROCESS
Applicant
Reynolds Laboratories
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Reynolds Laboratories
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number872.6475
Classification Product Code
EEG  
Date Received02/23/1979
Decision Date 04/10/1979
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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